Human serum albumin (hsa) fused to somatropin (DrugBank: Somatropin, Human serum albumin, Serum albumin)
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 | 14 |
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 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 |
| 6 | 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 | ||
| 7 | 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 a | Hungary;Czech Republic;Slovenia;Slovakia;Greece;Germany;Sweden | ||
| 8 | 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 | ||
| 9 | 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 a | United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 10 | 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 a | France;Hungary;Czech Republic;Slovakia;Slovenia;Greece;Denmark;Germany;Sweden | ||
| 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 |
| 11 | 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 a | France;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Denmark;Germany;Sweden | ||
| 12 | 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 a | United States;Serbia;Hungary;Czech Republic;Slovenia;Slovakia;Greece;Israel;Germany;Sweden | ||
| 13 | 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 a | United States;Serbia;France;Czech Republic;Hungary;Slovenia;Slovakia;Greece;Denmark;Israel;Germany;Sweden | ||
| 14 | 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 |