78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details
臨床試験数 : 494 / 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 |