78. 下垂体前葉機能低下症 Hypopituitarism Clinical trials / Disease details
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 | EUCTR2020-000929-42-NL (EUCTR) | 14/04/2022 | 23/02/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) 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: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL Product Name: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection Product Code: H01AC01 INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Turkey;Israel;United Kingdom;Italy;France;Armenia;Canada;Poland;Romania;Denmark;Australia;Georgia;Bulgaria;Netherlands;Germany;Japan;New Zealand | ||
| 2 | EUCTR2020-000929-42-BG (EUCTR) | 07/01/2022 | 20/01/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) 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: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL Product Name: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 3 | EUCTR2020-000929-42-DK (EUCTR) | 05/08/2021 | 12/01/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) 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: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan | ||
| 4 | EUCTR2020-000929-42-DE (EUCTR) | 09/06/2021 | 14/10/2020 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) 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: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | United States;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;New Zealand;Japan | ||
| 5 | EUCTR2020-000929-42-ES (EUCTR) | 21/04/2021 | 01/02/2021 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) 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: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL Product Name: Norditropin FlexPro 5 mg/1.5 ml INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Israel;Italy;France;Australia;Denmark;Netherlands;China;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan;Sweden | ||
| 6 | EUCTR2020-000929-42-SK (EUCTR) | 12/04/2021 | 24/11/2020 | Trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) 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: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Georgia;Bulgaria;Germany;New Zealand;Japan | ||
| 7 | EUCTR2020-000929-42-GR (EUCTR) | 23/03/2021 | 04/03/2021 | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | foresiGHt: A multicenter, randomized, parallel-arm, placebo- controlled (double- blind) and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency - foresiGHt | Adult Growth Hormone Deficiency (AGHD) 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: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Product Name: lonapegsomatropin drug product Product Code: ACP-011 INN or Proposed INN: LONAPEGSOMATROPIN Other descriptive name: TRANSCON PEG40 HGH Trade Name: Norditropin FlexPro 5 mg/1.5 mL INN or Proposed INN: Somatropin (recombinant DNA origin produced in E. coli) Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) Trade Name: Humatrope® 6 mg, powder and solvent for solution for injection INN or Proposed INN: Somatropin Other descriptive name: SOMATROPIN (recombinant DNA-derived human growth hormone) | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | Phase 3 | Belarus;Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Denmark;Australia;Netherlands;Turkey;United Kingdom;Armenia;Canada;Poland;Romania;Bulgaria;Georgia;Germany;Japan;New Zealand | ||
| 8 | 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 | ||
| 9 | EUCTR2016-001145-11-IT (EUCTR) | 07/04/2017 | 10/01/2017 | 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) | 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 CT-301 (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 Other descriptive name: recombinant DNA-derived human growth hormone Product Name: Sterile Water for Injection | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 10 | EUCTR2016-001145-11-PL (EUCTR) | 31/03/2017 | 17/01/2017 | 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) | 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 | United States;Belarus;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Chile;Russian Federation;Azerbaijan;Italy;France;Jordan;Australia;South Africa;Turkey;Lithuania;United Kingdom;Egypt;Armenia;Canada;Brazil;Poland;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | EUCTR2011-001826-61-BG (EUCTR) | 07/02/2014 | 12/09/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) 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: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 27 | EUCTR2012-002787-27-BG (EUCTR) | 11/09/2013 | 03/06/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children 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: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Armenia;Poland;Romania;Bulgaria;Germany | ||
| 28 | EUCTR2012-002787-27-SI (EUCTR) | 10/07/2013 | 10/07/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children 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: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 29 | EUCTR2012-002787-27-DE (EUCTR) | 17/06/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children 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: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 30 | EUCTR2012-002787-27-CZ (EUCTR) | 10/05/2013 | 19/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children 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: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 31 | 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 | |||
| 32 | EUCTR2012-002787-27-GR (EUCTR) | 04/03/2013 | 15/02/2013 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children 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: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany | ||
| 33 | EUCTR2012-002787-27-HU (EUCTR) | 11/02/2013 | 11/12/2012 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | Growth Hormone Deficiency (GHD) in pre-pubertal children 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: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;Egypt;France;Hungary;Czech Republic;Poland;Romania;Bulgaria;Germany | ||
| 34 | 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 | |||
| 35 | 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 | |||
| 36 | EUCTR2011-001826-61-PL (EUCTR) | 25/01/2012 | 12/09/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) 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: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 37 | 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 | |||
| 38 | 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 | ||
| 39 | 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 | |||
| 40 | EUCTR2011-001826-61-HU (EUCTR) | 29/07/2011 | 23/05/2011 | A study of HM10560A, a long-acting growth hormone product, for treatment of adult patients suffering from growth hormone deficiency | A phase II, randomized, active controlled, open label study of safety and efficacy of HM10560A a Long-acting rhGH-HMC001 conjugate in treatment of subjects suffering from adult growth hormone deficiency (AGHD) | Adult growth hormone deficiency (AGHD) 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: HM10560A Product Code: HM10560A Other descriptive name: chemical conjugate of recombinant human growth hormone (rhGH) and human immunoglobulin G4 fragment (HMC001) Trade Name: Genotropin INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Hanmi Pharmaceutical Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | Serbia;Hungary;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Korea, Republic of;India | ||
| 41 | EUCTR2010-019374-32-AT (EUCTR) | 15/02/2011 | 29/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Austria will be used in this clinical trial. Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Czech Republic;Hungary;Slovenia;Slovakia;Austria;Germany | ||
| 42 | EUCTR2010-019374-32-SI (EUCTR) | 13/09/2010 | 04/06/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Omnitrop Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: ecombinanat DNA-derived human growth h | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 43 | EUCTR2010-019374-32-HU (EUCTR) | 13/09/2010 | 18/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 44 | EUCTR2010-019374-32-CZ (EUCTR) | 06/09/2010 | 15/06/2010 | A study with MOD-4023 in patients with lack of Growth Hormone in the body | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 14.0;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 Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | Prolor Biotech Ltd | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Slovakia;Czech Republic;Serbia;Slovenia;Israel | ||
| 45 | EUCTR2010-019374-32-SK (EUCTR) | 15/07/2010 | 14/05/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Genotropin Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone produced in E.coli Trade Name: Humatrope Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Norditropin Simplex Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: Saizen Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth hormone produced in E.coli Trade Name: NutropinAq Product Name: recombinant human Growth Hormone(rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinanat DNA-derived human growth | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Germany;Czech Republic;Slovakia;Slovenia | ||
| 46 | 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 | |||
| 47 | EUCTR2010-019374-32-DE (EUCTR) | 07/12/2010 | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | A Phase II, Dose and Frequency Finding Study of MOD-4023 in Growth Hormone Deficient Adults (GHDA) | Growth Hormone Deficiency MedDRA version: 12.1;Level: LLT;Classification code 10056438;Term: Growth hormone deficiency | Product Name: n/a Product Code: MOD-4023 Trade Name: Only medicinal products registered in Germany will be used in this clinical trial Product Name: recombinant human Growth Hormone (rhGH) INN or Proposed INN: somatropin Other descriptive name: recombinant DNA-derived human growth hormone | ModigeneTech Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 2 | Hungary;Czech Republic;Slovakia;Germany;Slovenia | |||
| 48 | EUCTR2012-002787-27-FR (EUCTR) | 23/09/2015 | A study of ACP-001, a long-acting human growth hormone product, for treatment of Growth Hormone Deficiency in pre-pubertal children | A multicenter, Phase 2, randomized, open label, active-controlled, parallel-group study investigating the safety, tolerability, and efficacy of different dose levels of ACP-001 administered once weekly versus standard daily rhGH replacement therapy in pre-pubertal children with Growth Hormone Deficiency (GHD) | 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: ACP-001 Product Code: ACP-001 INN or Proposed INN: somatropin Other descriptive name: Transiently PEGylated hGH prodrug Trade Name: Genotropin Product Name: Recombinant human Growth Hormone (rhGH) Product Code: n/a INN or Proposed INN: SOMATROPIN Other descriptive name: recombinant DNA-derived human growth hormone | Ascendis Pharma A/S | NULL | Not Recruiting | Female: yes Male: yes | 52 | Phase 2 | Belarus;Slovenia;Greece;Ukraine;Turkey;Russian Federation;France;Egypt;Czech Republic;Hungary;Poland;Romania;Bulgaria;Germany |