78. Hypopituitarism Clinical trials / Disease details
Clinical trials : 494 / Drugs : 385 - (DrugBank : 49) / Drug target genes : 44 - 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | EUCTR2014-002039-32-DK (EUCTR) | 02/09/2014 | 07/07/2014 | Fatigue in patients with adrenal insufficiency - a comparison of the effect of a new modified-release hydrocortisone, and conventional hydrocortisone. | PlenadrEMA study - Effect of modified-release compared to conventional hydrocortisone on fatigue, measured by Ecological Momentary Assessments; a pilot study to assess feasibility, responsiveness of outcomes and to inform power calculations for future large-scale RCTs - PlenadrEMA study | Secondary adrenal insufficiency due to hypopituitarism MedDRA version: 20.0;Level: LLT;Classification code 10052382;Term: Secondary adrenal insufficiency;System Organ Class: 100000004860;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: Plenadren 5 mg modified-release tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Hydrocortisone TAKEDA, tabletter INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Product Name: Hydrokortison Glostrup 5 mg INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Plenadren 20 mg modified-release tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE | Rigshospitalet, Copenhagen University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Denmark | ||
| 8 | NCT01605331 (ClinicalTrials.gov) | December 2009 | 22/5/2012 | Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.) | Growth Hormone Deficiency | Drug: sustained-release recombinant human GH (SR-rhGH) | LG Life Sciences | NULL | Completed | 20 Years | N/A | Both | 132 | Phase 4 | NULL | |
| 9 | EUCTR2006-002278-24-IT (EUCTR) | 05/04/2007 | 16/12/2008 | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO | A phase III, open-label, uncontrolled, multicentre, rollover study to assess safety and efficacy of LB03002 administered weekly in adults with growth hormone deficiency. - BPLG-005-RO | Growth hormone deficiency MedDRA version: 9.1;Level: HLT;Classification code 10002701;Term: Anterior pituitary hypofunction | Product Name: LB03002 INN or Proposed INN: sustained release growth hormone | BIOPARTNERS GMBH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United Kingdom;Czech Republic;Germany;France;Spain;Italy;Austria;Sweden | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | NCT00271518 (ClinicalTrials.gov) | September 2005 | 29/12/2005 | Treatment of Children With Insufficient Secretion of 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 in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth Hormone | Growth Hormone Deficiency (GHD) | Drug: growth hormone (somatropin) | LG Life Sciences | BioPartners GmbH | Active, not recruiting | 3 Years | 11 Years | Both | 144 | Phase 3 | United States |
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 |
| 16 | EUCTR2004-002125-42-IT (EUCTR) | 22/09/2004 | 09/08/2007 | EFFECT OF PROLONGED TREATMENT WITH TH9507 ON IGF-I LEVELS IN ADOLESCENTS WITH ISOLATED GH DEFICIENCY DUE TO HYPOTHALAMIC PATHOGENESIS | EFFECT OF PROLONGED TREATMENT WITH TH9507 ON IGF-I LEVELS IN ADOLESCENTS WITH ISOLATED GH DEFICIENCY DUE TO HYPOTHALAMIC PATHOGENESIS | EVALUATION OF GROWTH HORMONE RELEASE | INN or Proposed INN: Somatorelin | AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 17 | NCT00600808 (ClinicalTrials.gov) | June 2003 | 23/7/2007 | Sustained Release Formulation of Somatropin (rDNA Origin)for Injection | A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency. | Growth Hormone Deficiency | Drug: BPLG-003 | BioPartners GmbH | LG Life Sciences | Completed | 4 Years | 10 Years | Both | 51 | Phase 2/Phase 3 | NULL |
| 18 | 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 |