78. 下垂体前葉機能低下症
［臨床試験数：462，薬物数：346（DrugBank：45），標的遺伝子数：41，標的パスウェイ数：80］
Searched query = "Hypopituitarism", "Anterior pituitary hypothyroidism", "Syndrome of abnormal secretion of gonadotropin", "Hyposecretion of gonadotropins", "Adrenocorticotropic hormone deficiency", "ACTH deficiency", "Thyroid-stimulating hormone deficiency", "TSH deficiency", "Growth hormone deficiency", "GH deficiency", "GHD", "CGHD", "AGHD", "Prolactin deficiency", "PRL deficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | NCT04326374 (ClinicalTrials.gov) | December 30, 2019 | 26/3/2020 | Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency | The Efficacy, Safety and Tolerability of TransCon hGH Administered Weekly Versus Daily hGH in Prepubertal Children With Growth Hormone Deficiency: a Randomized, Open-lable, Active-controlled, Parallel-group Study in China | Growth Hormone Deficiency;Endocrine System Diseases;Hormones;Pituitary Diseases;Pituitary Disease, Anterior | Drug: TransCon hGH;Drug: daily hGH | Visen Pharmaceuticals (Shanghai) Co., Ltd. | Ascendis Pharma A/S | Recruiting | 3 Years | 17 Years | All | 150 | Phase 3 | China |
| 2 | 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 | ||
| 3 | EUCTR2016-001145-11-IT (EUCTR) | 07/04/2017 | 10/01/2017 | 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: 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 INN or Proposed INN: Sterile Water Other descriptive name: STERILISED WATER FOR INJECTIONS | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | South Africa;Lithuania;Turkey;United Kingdom;Belarus;United States;Greece;Kyrgyzstan;Spain;Ukraine;Lebanon;Russian Federation;Chile;Azerbaijan;Italy;France;Jordan;Australia;Egypt;Armenia;Canada;Poland;Brazil;Romania;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 4 | EUCTR2016-001145-11-PL (EUCTR) | 31/03/2017 | 17/01/2017 | 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 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 INN or Proposed INN: lonapegsomatropin Other descriptive name: TRANSCON PEG40 HGH, Transiently PEGylated hGH prodrug | Ascendis Pharma Endocrinology Division A/S | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | 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 | ||
| 5 | 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] | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | 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 | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02781727 (ClinicalTrials.gov) | December 13, 2016 | 19/5/2016 | A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in 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, Pediatric;hGH (Human Growth Hormone);Endocrine System Diseases;Hormones;Pituitary Diseases | Drug: Once weekly subcutaneous injection of TransCon hGH;Drug: Once daily subcutaneous injection of Genotropin | Ascendis Pharma A/S | NULL | Completed | 3 Years | 12 Years | All | 161 | Phase 3 | United States;Armenia;Australia;Belarus;Bulgaria;Georgia;Greece;Italy;New Zealand;Poland;Romania;Russian Federation;Turkey;Ukraine |
| 7 | NCT01947907 (ClinicalTrials.gov) | July 2013 | 3/6/2013 | Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD) | 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) | Drug: ACP-001;Drug: Human Growth Hormone | Ascendis Pharma A/S | NULL | Completed | 3 Years | 12 Years | All | 53 | Phase 2 | Belarus;Bulgaria;Czech Republic;Egypt;France;Germany;Greece;Hungary;Poland;Romania;Russian Federation;Slovenia;Turkey;Ukraine |
| 8 | 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] | Ascendis Pharma Endocrinology Division A/S | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | 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 |