Recombinant human growth hormone ( DrugBank: Growth hormone, Human growth hormone, Recombinant human growth hormone )
4 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 78 | Hypopituitarism | 131 |
| 193 | Prader-Willi syndrome | 3 |
| 265 | Lipodystrophy | 2 |
| 276 | Achondroplasia | 1 |
78. Hypopituitarism
Clinical trials : 492 / Drugs : 341 - (DrugBank : 47) / Drug target genes : 45 - Drug target pathways : 100
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05355272 (ClinicalTrials.gov) | June 2023 | 20/4/2022 | Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT) | Growth Hormone Replacement Therapy in Veterans With Gulf War Illness and Adult Growth Hormone Deficiency | Gulf War Syndrome;Adult Growth Hormone Deficiency | Drug: Recombinant human growth hormone;Drug: Placebo | Baylor College of Medicine | United States Department of Defense | Not yet recruiting | 18 Years | 64 Years | All | 36 | Phase 2 | United States |
| 2 | ChiCTR2100048579 | 2021-08-01 | 2021-07-11 | Efficacy and Safety of JINTROLONG for Transitional Growth Hormone Deficiency | Efficacy and Safety of JINTROLONG for Transitional Growth Hormone Deficiency (TGHD) | Transitional Growth Hormone Deficiency | Experimental group:polyethylene glycol recombinant human growth hormone injection; | The Children's Hospital of Zhejiang University School of Medicine | NULL | Pending | 26 | Both | Experimental group:23; | Phase 4 | China | |
| 3 | EUCTR2020-000874-92-PL (EUCTR) | 22/03/2021 | 26/10/2020 | A Multicenter, 24-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Idiopathic Growth Hormone Deficiency (GHD) | A Multicenter, 24-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Idiopathic Growth Hormone Deficiency (GHD) - LUM-201-01 | Growth hormone deficiency MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: LUM-201 INN or Proposed INN: Ibutamoren mesilate Other descriptive name: IBUTAMOREN MESILATE Product Name: LUM-201 INN or Proposed INN: Ibutamoren mesilate Other descriptive name: IBUTAMOREN MESILATE Product Name: LUM-201 INN or Proposed INN: Ibutamoren mesilate Other descriptive name: IBUTAMOREN MESILATE Trade Name: Norditropin INN or Proposed INN: recombinant human growth hormone Other descriptive name: recombinant human growth hormone Trade Name: Norditropin INN or Proposed INN: recombinant human growth hormone Other descriptive name: recombinant human growth hormone | Lumos Pharma, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | United States;Poland;Ukraine;Australia;Russian Federation;Israel;New Zealand | ||
| 4 | ChiCTR2000039505 | 2020-12-01 | 2020-10-30 | An exploratory study of recombinant growth hormone in improving sexual dysfunction in male adult patients with growth hormone deficiency | An exploratory study of recombinant growth hormone in improving sexual dysfunction in male adult patients with growth hormone deficiency | Adult growth hormone deficiency | experimental group:Recombinant Human Growth Hormone; | Huashan Hospital Affiliated to Fudan University | NULL | Recruiting | 18 | 50 | Male | experimental group:20; | China | |
| 5 | NCT04020913 (ClinicalTrials.gov) | July 22, 2019 | 24/5/2019 | Skeletal Muscle Effects of GH in Boys | Recombinant Human Growth Hormone (GH): Effects on Metabolic Profile, Body Composition and Skeletal Muscle Strength and Function in Pre-pubertal Short Boys With and Without GH Deficiency | Growth Hormone Deficiency;Idiopathic Short Stature | Drug: Somatropin injection | Nemours Children's Clinic | Novo Nordisk A/S | Recruiting | 6 Years | 11 Years | Male | 45 | United States | |
| 6 | EUCTR2017-003410-20-RO (EUCTR) | 17/01/2019 | 13/05/2022 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 7 | EUCTR2017-003410-20-IT (EUCTR) | 30/10/2018 | 11/10/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;Germany | ||
| 8 | EUCTR2017-003410-20-PL (EUCTR) | 23/10/2018 | 08/11/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Belarus;United States;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Georgia;Bulgaria;Germany | ||
| 9 | EUCTR2017-003410-20-GR (EUCTR) | 04/06/2018 | 19/04/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 10 | EUCTR2017-003410-20-BG (EUCTR) | 20/04/2018 | 09/01/2018 | A long-term extension trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | enliGHten: A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth HormoneDeficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial - enliGHten | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH Product Name: TransCon hGH (ACP-011) INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Belarus;Greece;Ukraine;Turkey;Russian Federation;Italy;Armenia;Canada;Poland;Romania;Australia;Bulgaria;Georgia;New Zealand | ||
| 11 | EUCTR2016-001145-11-DE (EUCTR) | 12/02/2018 | 14/12/2016 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden;Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine | ||
| 12 | EUCTR2016-001145-11-GR (EUCTR) | 28/03/2017 | 02/02/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12,1mg INN or Proposed INN: TransCon hGH (ACP-011) Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 13 | EUCTR2015-001939-21-LV (EUCTR) | 15/08/2016 | 31/05/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 14 | NCT03015909 (ClinicalTrials.gov) | August 11, 2016 | 10/11/2016 | Evaluation of the Ease of Use, Preference, and Safety of EutropinPen Inj. | A Multi-center, Open, Single-arm, Switch-over, Prospective, Phase IV Study to Assess the Ease of Use, Preference, and Safety After 8 Weeks Subcutaneous Administration of EutropinPen Inj. in Patients Pretreated With Recombinant Human Growth Hormone by Reusable Device | Short Stature, Idiopathic;Infant, Small for Gestational Age;Growth Hormone Deficiency;Chronic Renal Failure;Turner Syndrome | Drug: Somatropin | LG Life Sciences | NULL | Completed | 4 Years | 15 Years | All | 116 | Phase 4 | Korea, Republic of |
| 15 | EUCTR2015-001939-21-LT (EUCTR) | 04/05/2016 | 29/02/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 16 | EUCTR2015-001939-21-PL (EUCTR) | 19/04/2016 | 18/01/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Belarus;Serbia;Estonia;Slovakia;Greece;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Hungary;Czech Republic;Poland;Latvia;Korea, Republic of | ||
| 17 | EUCTR2015-001939-21-EE (EUCTR) | 30/03/2016 | 16/02/2016 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 18 | NCT03223025 (ClinicalTrials.gov) | March 9, 2016 | 18/7/2017 | Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency | Efficacy and Safety of CinnaGen Recombinant Human Growth Hormone (CinnaTropin®) in Comparison With Novo Nordisk Growth Hormone (Nordilet®) Product in Pre-Pubertal Children With Idiopathic Growth Hormone Deficiency (IGHD) | Idiopathic Growth Hormone Deficiency | Drug: CinnaTropin®;Drug: Nordilet® | Cinnagen | NULL | Completed | 4 Years | 16 Years | All | 30 | Phase 3 | NULL |
| 19 | EUCTR2014-004525-41-PL (EUCTR) | 09/03/2016 | 23/02/2016 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH. | Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY | Growth hormone deficiency MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinant human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Versartis, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Belgium;Poland;Netherlands;Sweden | ||
| 20 | NCT03309891 (ClinicalTrials.gov) | January 18, 2016 | 5/9/2017 | Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency | A Phase 2, Randomized, Open-label, Active Controlled, Dose Finding Study of Long-acting Hybrid Fc Fused Recombinant Human Growth Hormone (GX-H9) in Paeditaric Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: GX-H9;Drug: Genotropin | Genexine, Inc. | NULL | Completed | 3 Years | 11 Years | All | 56 | Phase 2 | Ukraine |
| 21 | EUCTR2014-002736-13-PL (EUCTR) | 08/01/2016 | 29/09/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 22 | EUCTR2014-002736-13-HR (EUCTR) | 09/12/2015 | 01/02/2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 23 | EUCTR2015-001939-21-GR (EUCTR) | 12/11/2015 | 13/10/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Slovakia;Morocco;Greece;Spain;Ukraine;Lebanon;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Tunisia | ||
| 24 | EUCTR2015-001939-21-SK (EUCTR) | 22/10/2015 | 27/07/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia | ||
| 25 | EUCTR2014-002736-13-SI (EUCTR) | 15/10/2015 | 12/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 26 | EUCTR2015-001939-21-CZ (EUCTR) | 14/10/2015 | 10/07/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia | ||
| 27 | EUCTR2005-000384-26-FR (EUCTR) | 12/10/2015 | 04/10/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 138 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 28 | EUCTR2014-002736-13-CZ (EUCTR) | 01/10/2015 | 10/09/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 29 | EUCTR2014-004525-41-NL (EUCTR) | 03/09/2015 | 23/03/2015 | A Long-Acting Growth Hormone (VRS-317) in Children compared to Daily rhGH. | Comparison of VRS-317, a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinant human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Versartis, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 136 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 30 | EUCTR2014-002736-13-IT (EUCTR) | 25/08/2015 | 27/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 31 | EUCTR2014-002736-13-LT (EUCTR) | 20/08/2015 | 14/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 32 | EUCTR2014-002736-13-DE (EUCTR) | 19/08/2015 | 13/03/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 33 | EUCTR2014-002736-13-ES (EUCTR) | 24/07/2015 | 08/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 34 | EUCTR2015-001939-21-HU (EUCTR) | 16/07/2015 | 22/05/2015 | A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9 | A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: none Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 2 | Serbia;Belarus;Estonia;Slovakia;Greece;Ukraine;Lebanon;Turkey;Lithuania;Russian Federation;Hungary;Czech Republic;Poland;Romania;Latvia;Tunisia;Korea, Republic of | ||
| 35 | EUCTR2014-002698-13-PL (EUCTR) | 30/06/2015 | 22/05/2015 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 36 | EUCTR2014-002736-13-GR (EUCTR) | 26/06/2015 | 10/06/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden;Lithuania;Austria;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey | ||
| 37 | EUCTR2014-002736-13-HU (EUCTR) | 26/06/2015 | 10/04/2015 | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 38 | EUCTR2014-002736-13-AT (EUCTR) | 22/06/2015 | 04/05/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 39 | EUCTR2014-002698-13-DE (EUCTR) | 11/06/2015 | 23/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 40 | EUCTR2013-004468-69-PL (EUCTR) | 28/05/2015 | 05/02/2015 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 41 | EUCTR2014-002736-13-SE (EUCTR) | 25/05/2015 | 21/04/2015 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 42 | EUCTR2014-002736-13-SK (EUCTR) | 20/05/2015 | 15/01/2016 | A clinical study in adults with Growth Hormone Deficiency (GHD) to assess the safety and tolerability of weekly administered TV-1106 (experimental medicinal product) compared to daily administered growth hormone treatment (Genotropin®) | A phase 3, multicenter, randomized, open-label, comparator-controlled study to assess safety and tolerability of weekly TV-1106 compared to daily rhGH (Genotropin®) in adults with growth hormone-deficiency | Growth hormone deficiency MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) Trade Name: Genotropin Product Name: Somatropin; Recombinant Human Gowth Hormone Product Code: Not applicable INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Not available yet Other descriptive name: HUMAN SERUM ALBUMIN (HSA) FUSED TO RECOMBINANT HUMAN GROWTH HORMONE (HGH) | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;France;Peru;Slovenia;Turkey;Lithuania;Austria;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 43 | EUCTR2014-004525-41-BE (EUCTR) | 22/04/2015 | 16/02/2015 | A Long-Acting Growth Hormone (Somavaratan, VRS-317) in Children compared to Daily rhGH | Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: VRS-317 INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinant human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Versartis, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Poland;Belgium;Netherlands;Sweden | ||
| 44 | EUCTR2014-004525-41-SE (EUCTR) | 10/04/2015 | 12/02/2015 | A Long-Acting Growth Hormone, Somavaratan (VRS-317), in Children compared to Daily rhGH | Comparison of Somavaratan (VRS-317), a Long-acting Human Growth Hormone, to Daily rhGH in a Phase 3, Randomized, One-year, Open-label, Multi-center, Non-inferiority Trial in Pre-pubertal Children with Growth Hormone Deficiency. - VELOCITY | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Somavaratan (VRS-317) INN or Proposed INN: VRS-317 Other descriptive name: VRS-317 INN or Proposed INN: Recombinat human growth hormone Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Versartis, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;Canada;Poland;Belgium;Netherlands;Sweden | ||
| 45 | EUCTR2014-002698-13-GR (EUCTR) | 26/02/2015 | 17/03/2015 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 46 | EUCTR2013-004468-69-BG (EUCTR) | 18/02/2015 | 07/10/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 47 | EUCTR2014-002698-13-HU (EUCTR) | 17/02/2015 | 15/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 48 | EUCTR2014-002698-13-SE (EUCTR) | 03/02/2015 | 18/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 49 | EUCTR2013-004468-69-ES (EUCTR) | 22/01/2015 | 03/11/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 50 | EUCTR2014-002698-13-SK (EUCTR) | 14/01/2015 | 09/12/2014 | A clinical study in AGHD to assess safety, tolerability and efficacy of GX-H9 | A randomized, active-controlled, multiple-dose, open-label study to evaluate the safety, tolerability, and efficacy of the long-acting antibody-fused recombinant human growth hormone (GX-H9) in adult growth hormone deficiency (AGHD) | Adult Growth Hormone Deficiency (AGHD) MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: GX-H9 INN or Proposed INN: N/A Other descriptive name: hGH-hyFc, recombinant human growth hormone Trade Name: Genotropin® Product Name: Genotropin® INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Genexine, Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;France;Hungary;Slovakia;Greece;Poland;Germany;Korea, Republic of;Sweden | ||
| 51 | NCT02946606 (ClinicalTrials.gov) | January 2015 | 28/8/2015 | A Clinical Study in AGHD to Assess Safety, Tolerability and Efficacy of GX-H9 | A Randomized, Active-controlled, Multiple-dose, Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of the Long-acting Antibody-fused Recombinant Human Growth Hormone (GX-H9) in Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: GX-H9;Drug: Genotropin | Genexine, Inc. | NULL | Completed | 20 Years | 65 Years | All | 45 | Phase 2 | Korea, Republic of |
| 52 | EUCTR2013-004468-69-CZ (EUCTR) | 08/08/2014 | 11/04/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth hormone deficiency MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 53 | EUCTR2013-004468-69-GR (EUCTR) | 29/07/2014 | 16/06/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | ||
| 54 | EUCTR2013-004468-69-HU (EUCTR) | 11/06/2014 | 21/02/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone(Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-DeficientChildren | Growth hormone deficiency MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;Belarus;Slovenia;Greece;Spain;Ukraine;Turkey;Russian Federation;Israel;Hungary;Czech Republic;Poland;Romania;Bulgaria;Georgia | ||
| 55 | EUCTR2013-000830-37-PL (EUCTR) | 11/06/2014 | 03/01/2014 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 56 | NCT02092077 (ClinicalTrials.gov) | April 30, 2014 | 14/3/2014 | A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth Hormone-Deficiency | Drug: TV-1106;Drug: somatropin | Teva Pharmaceutical Industries, Ltd. | NULL | Terminated | 3 Years | 11 Years | All | 65 | Phase 2 | Belarus;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Spain;Turkey;Ukraine;Czech Republic;Slovenia |
| 57 | EUCTR2011-001826-61-BG (EUCTR) | 07/02/2014 | 12/09/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 58 | EUCTR2013-000830-37-NL (EUCTR) | 02/01/2014 | 29/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Netherlands;Germany | ||
| 59 | EUCTR2013-000830-37-ES (EUCTR) | 12/10/2013 | 12/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | PROLOR Biotech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;France;Hungary;Poland;Romania;Netherlands;Germany | ||
| 60 | EUCTR2013-000830-37-GB (EUCTR) | 30/09/2013 | 09/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Armenia;Poland;Romania;Australia;Georgia;Germany;Netherlands;Korea, Republic of | ||
| 61 | EUCTR2013-000830-37-GR (EUCTR) | 12/09/2013 | 03/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | PROLOR Biotech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Poland;Romania;Germany;Netherlands | ||
| 62 | EUCTR2012-002787-27-BG (EUCTR) | 11/09/2013 | 03/06/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Armenia;Poland;Romania;Bulgaria;Germany | ||
| 63 | EUCTR2012-004975-37-SE (EUCTR) | 05/09/2013 | 09/07/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 16.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Hungary;Czech Republic;Slovenia;Slovakia;Greece;Germany;Sweden | ||
| 64 | EUCTR2013-000830-37-SK (EUCTR) | 04/09/2013 | 24/05/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Serbia;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 65 | EUCTR2013-000830-37-AT (EUCTR) | 29/08/2013 | 11/07/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 66 | EUCTR2012-004975-37-DE (EUCTR) | 05/08/2013 | 02/05/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 67 | EUCTR2012-002787-27-SI (EUCTR) | 10/07/2013 | 10/07/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 68 | EUCTR2013-000830-37-HU (EUCTR) | 03/07/2013 | 23/05/2013 | Treatment with Long Acting hGH Product in Adult subjects with Growth Hormone Deficiency | A Phase 3, Multicenter Study Designed to Evaluate the Efficacy and Safety of a Long Acting hGH Product (MOD-4023) in Adult Subjects with Growth Hormone Deficiency | Adult or childhood onset growth hormone deficiency (GHD) MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: na Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Serbia;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;France;Hungary;Poland;Romania;Australia;Georgia;Netherlands;Germany;Korea, Republic of | ||
| 69 | EUCTR2012-004975-37-CZ (EUCTR) | 20/06/2013 | 04/01/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 70 | EUCTR2012-002787-27-DE (EUCTR) | 17/06/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 71 | EUCTR2012-004975-37-SI (EUCTR) | 22/05/2013 | 17/04/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hungary;Czech Republic;Slovakia;Slovenia;Greece;Denmark;Germany;Sweden | ||
| 72 | EUCTR2012-002787-27-CZ (EUCTR) | 10/05/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 73 | EUCTR2011-004553-60-PL (EUCTR) | 02/04/2013 | 09/02/2012 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: no INN available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: no INN available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 74 | NCT01811576 (ClinicalTrials.gov) | March 31, 2013 | 12/3/2013 | A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency | A 64-Week (12-week Core Phase and 52-week Safety Extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: TV-1106;Drug: Recombinant human growth hormone | Teva Branded Pharmaceutical Products R&D, Inc. | NULL | Completed | 23 Years | 65 Years | All | 52 | Phase 2 | United States;Czechia;Germany;Greece;Hungary;Israel;Serbia;Slovakia;Slovenia;Czech Republic;Sweden |
| 75 | EUCTR2012-004975-37-GR (EUCTR) | 27/03/2013 | 29/03/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Denmark;Germany;Sweden | ||
| 76 | EUCTR2012-002787-27-GR (EUCTR) | 04/03/2013 | 15/02/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 77 | EUCTR2012-004975-37-SK (EUCTR) | 27/02/2013 | 04/03/2013 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 78 | EUCTR2012-002787-27-HU (EUCTR) | 11/02/2013 | 11/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 79 | EUCTR2012-004975-37-HU (EUCTR) | 21/01/2013 | 23/11/2012 | A clinical study in patients with Growth Hormone Deficiency to assess safety , tolerability and efficacy of TV-1106 (experimental drug). | A 64-Week (12-week core phase and 52-week safety extension), Phase II, Multicenter, Randomized, Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults with Growth Hormone Deficiency | Growth hormone deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin® Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden | ||
| 80 | EUCTR2011-004553-60-BG (EUCTR) | 02/07/2012 | 10/04/2012 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 81 | EUCTR2011-004553-60-CZ (EUCTR) | 10/04/2012 | 06/12/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | PROLOR Biotech Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 82 | EUCTR2011-001826-61-PL (EUCTR) | 25/01/2012 | 12/09/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 83 | EUCTR2011-004553-60-GR (EUCTR) | 23/01/2012 | 27/12/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 14.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | PROLOR Biotech Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Hungary;Czech Republic;Russian Federation;Ukraine;Belarus;Greece;Macedonia, the former Yugoslav Republic of;Israel | |||
| 84 | EUCTR2011-004553-60-SK (EUCTR) | 10/01/2012 | 24/11/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency MedDRA version: 17.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: Not available yet Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: Not available yet Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 85 | EUCTR2011-004553-60-HU (EUCTR) | 10/01/2012 | 03/11/2011 | A study of MOD-4023 compared with daily GH therapy in children with lack of growth hormone in the body | Safety and dose finding study of different MOD-4023 dose levelscompared to daily r-hGH therapy in pre-pubertal growth hormonedeficient children | Pediatric Growth Hormone Deficiency;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available Product Name: n/a Product Code: MOD-4023 INN or Proposed INN: not available Trade Name: Genotropin Product Name: Recombinant human Growth Hormone INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli | OPKO Biologics Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 2 | Belarus;United States;Czech Republic;Hungary;Slovakia;Greece;Poland;Ukraine;Bulgaria;Russian Federation | ||
| 86 | NCT01822340 (ClinicalTrials.gov) | October 2011 | 25/3/2013 | Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients | A Phase II, Randomized, Active Controlled, Open Label Study of Safety and Efficacy of HM10560A a Long-acting rhGH-HMC001 Conjugate in Treatment of Subjects Suffering From Adult Growth Hormone Deficiency (AGHD) | Adult Growth Hormone Deficiency | Drug: HM10560A;Drug: Genotropin | Hanmi Pharmaceutical Company Limited | NULL | Completed | 23 Years | 60 Years | Both | 72 | Phase 2 | Hungary;Romania |
| 87 | EUCTR2011-000460-10-CZ (EUCTR) | 22/08/2011 | 22/06/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy powder for solution for injection Product Name: NA Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono S.A. Geneva | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy | ||
| 88 | EUCTR2011-000460-10-ES (EUCTR) | 16/08/2011 | 21/06/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | Idiopathic Growth Hormone Deficiency and Turner Syndrome MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 14.0;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy power for solution for injection Product Name: NA Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono S.A. Geneva | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | France;Czech Republic;Canada;Argentina;Spain;United Kingdom;Italy | ||
| 89 | EUCTR2011-000460-10-GB (EUCTR) | 03/08/2011 | 17/05/2011 | Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients | First year growth response associated geneticmarkers validation Phase IV open-label study inGrowth Hormone Deficient and Turner Syndromepre-pubertal children : the PREDICTPharmacogenetics Validation Study - PREDICT PGx Validation Study | idiopathic growth hormone deficientyTurner Syndrome MedDRA version: 13.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders MedDRA version: 13.1;Classification code 10045181;Term: Turner's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Trade Name: Saizen 8mg click.easy powder for solution for injection Product Name: Saizen 8mg click.easy powder for solution for injection Product Code: NA INN or Proposed INN: somatropin Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Merck Serono SA | NULL | Not Recruiting | Female: yes Male: yes | 395 | Phase 4 | Czech Republic;Canada;Spain;Russian Federation;Italy;United Kingdom | ||
| 90 | EUCTR2011-001826-61-HU (EUCTR) | 29/07/2011 | 23/05/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 91 | EUCTR2010-019374-32-AT (EUCTR) | 15/02/2011 | 29/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Austria will be used in this clinical trial. Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany | ||
| 92 | EUCTR2010-019374-32-SI (EUCTR) | 13/09/2010 | 04/06/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Omnitrop Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: ecombinanat DNA-derived human growth h | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 93 | EUCTR2010-019374-32-HU (EUCTR) | 13/09/2010 | 18/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 94 | EUCTR2010-019374-32-CZ (EUCTR) | 06/09/2010 | 15/06/2010 | A study with MOD-4023 in patients with lack of Growth Hormone in the body | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 14.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: n/a Product Code: MOD-4023 Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Prolor Biotech Ltd | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel | ||
| 95 | EUCTR2010-019374-32-SK (EUCTR) | 15/07/2010 | 14/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 96 | EUCTR2009-016783-37-SE (EUCTR) | 07/01/2010 | 16/10/2009 | The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH | The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of Life in GHD adults - VLAD-GH | Growth hormone deficiency in adults | Product Name: Genotropin, Genotropin MiniQuick Product Code: H01AC01 INN or Proposed INN: recombinant human growth hormone | Sahlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Sweden | |||
| 97 | EUCTR2007-001746-40-HU (EUCTR) | 25/08/2008 | 02/04/2007 | A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) | A Phase IIb study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of ARX201 Following Repeated Dosing to Young Adult Patients with Childhood Onset Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: ARX201 Other descriptive name: Pegylated recombinant human growth hormone | Ambrx, Inc., USA | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Hungary | ||
| 98 | NCT00684957 (ClinicalTrials.gov) | January 2008 | 23/5/2008 | Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors | Differential Effects of rhGH vs. rhIGF-1 on Cardiovascular Risk Factors in Adult Patients With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: Recombinant Human Growth Hormone;Drug: Recombinant human IGF-1 | Columbia University | Tercica | Terminated | 25 Years | 65 Years | Male | 5 | N/A | United States |
| 99 | EUCTR2006-002278-24-SE (EUCTR) | 15/05/2007 | 05/03/2007 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 100 | EUCTR2006-002278-24-GB (EUCTR) | 02/05/2007 | 23/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 101 | EUCTR2006-002278-24-SK (EUCTR) | 20/04/2007 | 22/03/2007 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Sciences Ltd. | BioPartners GmbH | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 102 | EUCTR2006-002278-24-FR (EUCTR) | 13/04/2007 | 24/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 103 | NCT01187550 (ClinicalTrials.gov) | March 2007 | 22/8/2010 | Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen® | A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen® | Dwarfism, Pituitary | Drug: Recombinant human growth hormone (r-hGH) | Merck KGaA | Merck Serono Co., Ltd., China | Completed | N/A | N/A | All | 214 | Phase 4 | NULL |
| 104 | EUCTR2006-002278-24-AT (EUCTR) | 05/01/2007 | 10/11/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Sciences Ltd. | BioPartners GmbH | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 105 | EUCTR2005-000346-36-LT (EUCTR) | 29/12/2006 | 24/10/2006 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 9.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Sweden;Lithuania | ||
| 106 | EUCTR2006-002278-24-CZ (EUCTR) | 14/12/2006 | 08/09/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | ||
| 107 | EUCTR2006-002278-24-ES (EUCTR) | 13/12/2006 | 10/03/2010 | Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Estudio en fase III, abierto, no controlado, multicéntrico y de continuidad terapéutica, para evaluar la seguridad y la eficacia de LB03002 administrado una vez a la semana en adultos con deficiencia de la hormona de crecimiento.A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 108 | EUCTR2006-002278-24-DE (EUCTR) | 06/10/2006 | 15/08/2006 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 109 | EUCTR2005-000384-26-DE (EUCTR) | 20/12/2005 | 02/06/2006 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;Spain;Sweden | ||
| 110 | EUCTR2005-000384-26-AT (EUCTR) | 10/11/2005 | 10/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Science Ltd. | BioPartners | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | Czech Republic;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 111 | EUCTR2005-000384-26-SK (EUCTR) | 27/10/2005 | 19/09/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 138 | Phase 3 | Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 112 | EUCTR2005-000384-26-GB (EUCTR) | 21/10/2005 | 17/08/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Spain;Austria;Germany;United Kingdom;Sweden | ||
| 113 | EUCTR2005-000384-26-CZ (EUCTR) | 30/09/2005 | 08/08/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 114 | EUCTR2005-000346-36-FI (EUCTR) | 22/09/2005 | 30/05/2005 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 115 | EUCTR2005-000384-26-SE (EUCTR) | 13/09/2005 | 27/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency. | Growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 116 | EUCTR2005-000384-26-ES (EUCTR) | 22/08/2005 | 27/06/2005 | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento | A phase III, double-blind, randomized, placebo-controlled, parallel-group, multicenter study to assess efficacy and safety of LB03002 administered weekly in adults with growth hormone deficiency.Estudio de fase III, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la eficacia y la seguridad de LB03002 administrado una vez a la semana en adultos con deficiencia de hormona del crecimiento | growth hormone deficiency in adults MedDRA version: 8.0;Level: PT;Classification code 10056438 | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) | LG Life Science Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 138 | Phase 3 | Germany;United Kingdom;Czech Republic;Spain;Sweden | ||
| 117 | EUCTR2005-000346-36-SE (EUCTR) | 18/08/2005 | 16/06/2005 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Hungary;Finland;Germany;Czech Republic;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 118 | EUCTR2005-000346-36-DE (EUCTR) | 16/08/2005 | 06/06/2006 | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy with Genotropin® in Treatment Naive Children with Growth Failure due to Insufficient Secretion of Endogenous Growth Hormone | pre-pubertal drug naïve growth-deficient children with insufficient endogenous growth hormone secretion MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Code: LB03002 INN or Proposed INN: somatropin Other descriptive name: recombinant human growth hormone (rhGH) Trade Name: Genotropin Product Name: Genotropin Product Code: Genotropin INN or Proposed INN: Somatropin | BioPartners GmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Finland;Czech Republic;Germany;Estonia;Italy;Latvia;Austria;Lithuania;Sweden | ||
| 119 | NCT00297713 (ClinicalTrials.gov) | July 2005 | 27/2/2006 | Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety | A Phase II, Multi-Center, Multi-Dose, Randomized, Open-Label, Parallel Group Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety | Adult Growth Hormone Deficiency | Drug: ALTU-238 | Altus Pharmaceuticals | NULL | Completed | 18 Years | 60 Years | Both | 12 | Phase 2 | United States |
| 120 | NCT00109733 (ClinicalTrials.gov) | January 2005 | 2/5/2005 | Cool.Click™ Adolescent Transition Study: Study of Saizen® in Subjects With Childhood-onset Growth Hormone Deficiency | A Phase IIIb, Prospective, Multicenter, Randomized, Open-label Study to Determine the Safety and Efficacy of Two Different Dosing Regimens of Saizen® (Recombinant Human Growth Hormone (r-hGH), Using Cool.Click™ in Subjects With Childhood-onset Growth Hormone Deficiency During the Adolescent Transition Phase (CATS) | Childhood-onset Growth Hormone Deficiency;Pituitary Dwarfism | Biological: recombinant human growth hormone | EMD Serono | NULL | Completed | 13 Years | 25 Years | All | 31 | Phase 3 | United States |
| 121 | NCT00182091 (ClinicalTrials.gov) | August 2004 | 14/9/2005 | Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency | Effects of Physiologic Growth Hormone Administration on Cardiovascular Risk in Subjects With Growth Hormone Deficiency Following Cure of Acromegaly | Acromegaly;Growth Hormone Deficiency;Pituitary Disease | Drug: Recombinant human growth hormone;Drug: Saline | Massachusetts General Hospital | NULL | Completed | 18 Years | 85 Years | All | 75 | N/A | United States |
| 122 | NCT00957671 (ClinicalTrials.gov) | November 2003 | 10/8/2009 | Anterior Pituitary Hormone Replacement in Traumatic Brain Injury | Anterior Pituitary Hormone Replacement in Traumatic Brain Injury | Growth Hormone Deficiency;Traumatic Brain Injury | Drug: Recombinant human growth hormone | The University of Texas Medical Branch, Galveston | The Moody Foundation | Completed | 21 Years | N/A | All | 15 | Phase 4 | United States |
| 123 | NCT00929799 (ClinicalTrials.gov) | November 2003 | 29/6/2009 | Growth Hormone and Glucose Metabolism | Effects of Treatment With Human Growth Hormone on Insulin Resistance and Insulin Secretion in Adults With Growth Hormone Deficiency | Growth Hormone Deficiency | Drug: recombinant human Growth Hormone (Genotropin® ) | Charite University, Berlin, Germany | NULL | Completed | 18 Years | N/A | Both | 6 | Phase 4 | Germany |
| 124 | NCT01009905 (ClinicalTrials.gov) | June 24, 2002 | 5/11/2009 | An Observational Study (Registry) Assessing Treatment Outcomes and Safety for Children and Adults Who Are Prescribed Norditropin® (Human Growth Hormone) | Registry of Patients Being Treated With Norditropin®, Recombinant Human Growth Hormone | Growth Hormone Disorder;Pituitary Dwarfism;Hypopituitarism | Drug: somatropin | Novo Nordisk A/S | NULL | Completed | N/A | 18 Years | All | 22960 | N/A | United States |
| 125 | NCT00458991 (ClinicalTrials.gov) | June 2001 | 9/4/2007 | rhGH Therapy on Hepatic Drug Metabolism | Recombinant Human Growth Hormone Therapy and Drug Metabolism | Growth Hormone Deficiency, Dwarfism | Drug: Dextromethorphan and Caffeine | University of Louisville | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | 4 Years | 14 Years | All | 9 | N/A | United States |
| 126 | NCT00174278 (ClinicalTrials.gov) | February 1997 | 9/9/2005 | Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary | Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety. | Growth Hormone Deficiency;Growth Retardation | Drug: Somatropin | Pfizer | NULL | Completed | 6 Years | N/A | Both | 14 | Phase 3 | France |
| 127 | EUCTR2012-002787-27-FR (EUCTR) | 23/09/2015 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;France;Egypt;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | |||
| 128 | EUCTR2010-019374-32-DE (EUCTR) | 07/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Germany will be used in this clinical trial Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Czech Republic;Slovakia;Germany;Slovenia | |||
| 129 | EUCTR2013-004468-69-RO (EUCTR) | 02/06/2014 | A clinical study in children with Growth Hormone Deficiency for dose-finding and assessment of safety of TV-1106 (experimental drug). | A Phase 2, Randomized, Open-Label, Safety and Dose-Finding Study Comparing 3 Different Doses of Weekly TV-1106 and Daily Recombinant Human Growth Hormone (Genotropin®) Therapy in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children | Growth hormone deficiency MedDRA version: 17.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Albutropin Product Code: TV1106 INN or Proposed INN: Albutropin Other descriptive name: human Serum Albumin (HSA) fused to somatropin Product Name: Albutropin Product Code: TV-1106 INN or Proposed INN: Albutropin Other descriptive name: Human Serum Albumin (HSA) fused to somatropin Trade Name: Genotropin Product Name: Recombinant Human Gowth Hormone Product Code: n/a INN or Proposed INN: somatropin Other descriptive name: SOMATROPIN | Teva Pharmaceutical Industries, Ltd. | NULL | NA | Female: yes Male: yes | 60 | Phase 2 | Belarus;Serbia;Greece;Spain;Ukraine;Turkey;Israel;Russian Federation;Czech Republic;Hungary;Poland;Romania;Bulgaria;Georgia | |||
| 130 | EUCTR2016-000446-56-Outside-EU/EEA (EUCTR) | 07/03/2016 | Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone. | Clinical study to compare recombinant human growth hormone Cristalia(r-hGH Cristalia) versus Genotropin® in prepubertal children withgrowth deficiency due to deficiency of growth hormone. - CERES | Growth deficiency due to growth hormone deficiency MedDRA version: 18.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: NA Product Code: NA INN or Proposed INN: NA Other descriptive name: SOMATROPIN Trade Name: Genotropin Product Name: Genotropin INN or Proposed INN: NA Other descriptive name: SOMATROPIN | Cristália Produtos Químicos Farmacêuticos Ltda. | NULL | NA | Female: yes Male: yes | 94 | Brazil | ||||
| 131 | EUCTR2016-001145-11-BG (EUCTR) | 11/01/2017 | A trial of TransCon hGH, a sustained-release recombinant human growth hormone product, for treatment of Growth Hormone Deficiency in prepubertal children | A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) | Growth hormone deficiency (GHD) in prepubertal children MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: TransCon hGH (ACP-011) - 12.1mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug Trade Name: GENOTROPIN 12 mg powder and solvent for solution for injection. Product Name: GENOTROPIN 12 mg powder and solvent for solution for injection. INN or Proposed INN: Somatropin Other descriptive name: recombinant DNA-derived human growth hormone Product Name: TransCon hGH (ACP-011) - 24.2mg INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Lithuania;Turkey;United Kingdom;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden |
193. Prader-Willi syndrome
Clinical trials : 113 / Drugs : 111 - (DrugBank : 26) / Drug target genes : 48 - Drug target pathways : 102
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR2100046551 | 2021-05-18 | 2021-05-21 | Multimodal magnetic resonance imaging changes in Prader-Willi syndrome before and after growth hormone treatment | Application of multimodal magnetic resonance imaging in pre - and post-treatment evaluation of recombinant human growth hormone in children with Prader-Willi syndrome | Prader-Willi sydrome | Prader-Willi sydrome group treated with rhGH:Treat with rhGH;Prader-Willi sydrome group treated without rhGH:Basic medicine;Normal development group:none; | Cai Jinhua | NULL | Recruiting | 0 | 16 | Both | Prader-Willi sydrome group treated with rhGH:40;Prader-Willi sydrome group treated without rhGH:40;Normal development group:40; | N/A | China |
| 2 | NCT03554031 (ClinicalTrials.gov) | April 14, 2018 | 30/5/2018 | A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome | A Single Arm, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome | Prader-Willi Syndrome | Drug: Recombinant Human Growth Hormone (rhGH) Injection | GeneScience Pharmaceuticals Co., Ltd. | Children's Hospital of Fudan University;Tongji medical college huazhong university of science & technology;Beijing Children's Hospital;Peking University First Hospital;Peking Union Medical College Hospital;The Children's Hospital of Zhejiang University School of Medicine | Unknown status | 1 Month | 5 Years | All | 30 | Phase 3 | China |
| 3 | EUCTR2017-002164-41-ES (EUCTR) | 03/07/2017 | 21/06/2017 | Study with adult patients with Prader-Willi syndrome, which evaluate the effect of growth hormone therapy on muscle tone and its relation with muscle strength and body composition assessed with imaging procedures. | Growth hormone therapy in adults with Prader-Willi syndrome: Effect on muscle tone assessed by functional magnetic resonance imaging (fMRI) and its relation to muscle strenght and body composition. | Patients with Prader-Willi Syndrome (SPW) with Growth hormone deficit. MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Genotonorm Miniquick 0,2 mg INN or Proposed INN: RECOMBINANT HUMAN GROWTH HORMON Other descriptive name: RECOMBINANT HUMAN GROWTH HORMONE | Fundació Parc Taulí | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Spain |
265. Lipodystrophy
Clinical trials : 112 / Drugs : 155 - (DrugBank : 55) / Drug target genes : 25 - Drug target pathways : 97
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00130286 (ClinicalTrials.gov) | March 2005 | 12/8/2005 | Growth Hormone and/or Rosiglitazone for HIV-Associated Increased Abdominal Fat and Insulin Resistance | Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Recombinant Human Growth Hormone and/or Rosiglitazone in the Treatment of Human Immunodeficiency Virus-Associated Visceral Adiposity and Insulin Resistance | HIV-Associated Lipodystrophy Syndrome;Insulin Resistance;HIV Infections;Metabolic Syndrome X;Body Weight Changes | Drug: Rosiglitazone;Drug: Recombinant human growth hormone + rosiglitazone | Weill Medical College of Cornell University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | 65 Years | All | 77 | Phase 1/Phase 2 | United States |
| 2 | NCT00100698 (ClinicalTrials.gov) | January 2004 | 4/1/2005 | Physiologic Growth Hormone Effects in HIV Lipodystrophy | Physiologic Growth Hormone Effects in HIV Lipodystrophy | AIDS;HIV Infections | Drug: recombinant human growth hormone;Drug: placebo | Massachusetts General Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | 60 Years | All | 56 | N/A | United States |
276. Achondroplasia
Clinical trials : 51 / Drugs : 34 - (DrugBank : 6) / Drug target genes : 4 - Drug target pathways : 26
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05353192 (ClinicalTrials.gov) | September 23, 2022 | 25/4/2022 | A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia | A Multicenter, Open-label, Single Arm Phase IV Clinical Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Achondroplasia | Achondroplasia | Drug: Recombinant human growth hormone | GeneScience Pharmaceuticals Co., Ltd. | Children's Hospital of Fudan University;Tongji Hospital;Children's Hospital of Nanjing Medical University;Jiangxi Province Children's Hospital;Chengdu Women's and Children's Central Hospital;Shandong Provincial Hospital;Shengjing Hospital;Shanghai Children's Hospital;Children's Hospital of The Capital Institute of Pediatrics;West China Second University Hospital, Sichuan University | Recruiting | 2 Years | 10 Years | All | 38 | Phase 4 | China |