HGH-hyFc, recombinant human growth hormone ( DrugBank: Growth hormone, Human growth hormone, Recombinant human growth hormone )
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 |
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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 |