R-hGH ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 78 | 下垂体前葉機能低下症 | 16 |
78. 下垂体前葉機能低下症
臨床試験数 : 492 / 薬物数 : 341 - (DrugBank : 47) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 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 | 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 | |||
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | NCT01592500 (ClinicalTrials.gov) | February 2012 | 2/5/2012 | Safety and Efficacy Phase 2 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily r-hGH Therapy in Pre-pubertal Growth Hormone Deficient Children | Pediatric Growth Hormone Deficiency | Drug: MOD-4023;Drug: Somatropin | OPKO Health, Inc. | NULL | Completed | 3 Years | 11 Years | All | 56 | Phase 2 | Greece;Hungary;Slovakia |
| 5 | 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 | |||
| 6 | 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 | ||
| 7 | 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 | |||
| 8 | EUCTR2010-023430-23-GB (EUCTR) | 28/03/2011 | 24/01/2011 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;Czech Republic;United Kingdom | |||
| 9 | EUCTR2010-023430-23-CZ (EUCTR) | 09/02/2011 | 25/11/2010 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;United Kingdom;Czech Republic | |||
| 10 | EUCTR2010-023430-23-HU (EUCTR) | 17/01/2011 | 10/11/2010 | A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD) - | This is GH replacement therapy in adult subjects with documented Growth Hormone Deficiency (GHD) either idiopathic or acquired and childhood- or adult-onset MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Trade Name: Saizen Product Name: Saizen Product Code: NA INN or Proposed INN: SOMATROPIN | Merck Serono S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | Hungary;United Kingdom;Czech Republic | |||
| 11 | NCT01237340 (ClinicalTrials.gov) | October 2010 | 5/11/2010 | Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study | A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) | Drug: Saizen® | EMD Serono | NULL | Terminated | 18 Years | 60 Years | All | 59 | Phase 3 | United States |
| 12 | NCT01034735 (ClinicalTrials.gov) | July 2008 | 16/12/2009 | r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial | Phase I, Open Label, Randomised Three-way Cross Over, Single-centre Trial to Assess the Bioequivalence for Two Concentrations of the New r-hGH Liquid Multidose Formulation Versus the r-hGH Freeze-dried Multidose Formulation Administered in Healthy Volunteers | Growth Failure;Growth Hormone Deficiency | Biological: r-hGH liquid (Saizen);Biological: r-hGH freeze-dried | EMD Serono | NULL | Completed | 18 Years | 45 Years | Both | 30 | Phase 1 | Germany |
| 13 | 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 |
| 14 | 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 |
| 15 | NCT01157793 (ClinicalTrials.gov) | September 2003 | 6/7/2010 | A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in Growth Hormone Deficient(GHD) Subjects During the Transition Phase From Childhood to Adulthood | A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in GHD Subjects During the Transition Phase From Childhood to Adulthood | Dwarfism;Growth Hormone Deficiency | Drug: r-hGH | Merck KGaA | NULL | Completed | 14 Years | 25 Years | Both | 34 | Phase 4 | NULL |
| 16 | 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 |