81. 先天性副腎皮質酵素欠損症 Congenital adrenal hyperplasia Clinical trials / Disease details
臨床試験数 : 87 / 薬物数 : 87 - (DrugBank : 23) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 68
| 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 | NCT04536662 (ClinicalTrials.gov) | October 1, 2020 | 23/8/2020 | Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase Deficiency | Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase Deficiency | Congenital Adrenal Hyperplasia | Drug: Hydrocortisone;Drug: Prednisone;Drug: Dexamethasone | Shanghai Jiao Tong University School of Medicine | NULL | Not yet recruiting | 14 Years | 45 Years | All | 120 | Phase 4 | China |
| 2 | EUCTR2015-000711-40-DK (EUCTR) | 08/09/2016 | 11/07/2016 | Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 10mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 0,1 mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 2,5 mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE Product Name: Hydrocortisone tablet 2.5 mg | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 3 | NCT03760835 (ClinicalTrials.gov) | August 11, 2016 | 9/11/2018 | Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment | Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment | Congenital Adrenal Hyperplasia | Drug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone);Drug: Dual release hydrocortisone (plenadren) | Federico II University | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 4 | Italy |
| 4 | EUCTR2015-000711-40-DE (EUCTR) | 23/05/2016 | 06/10/2015 | Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Chronocort® 5 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Hydrocortisone 10mg Tablet INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Product Name: Dexamethasone 0.5mg Tablet INN or Proposed INN: DEXAMETHASONE Product Name: Prednisolone 5mg Tablet INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE Product Name: Chronocort® 10 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® 20 mg | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 5 | EUCTR2015-000711-40-NL (EUCTR) | 28/04/2016 | 17/11/2015 | Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 18.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 20mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 1,5 mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 5 mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 110 | Phase 3 | United States;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 6 | EUCTR2015-000711-40-SE (EUCTR) | 11/01/2016 | 13/10/2015 | Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000012082;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 20mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 2mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 1mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 7 | EUCTR2015-000711-40-GB (EUCTR) | 19/11/2015 | 28/07/2015 | Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently used glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia seeking to assess its safety, tolerability and effectiveness. | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. | Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of the adrenal cortex characterised by cortisol deficiency with or without aldosterone deficiency, and androgen excess. Subjects with CAH are at risk of developing a number of clinical manifestations, such as obesity in children, insulin resistance, and polycystic ovaries, which may contribute to infertility in women with CAH. Oligomenorrhoea or amenorrhoea may be present in adolescence. MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Trade Name: Hydrocortisone 20mg Tablets INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Trade Name: Dexamethasone 2mg Tablets INN or Proposed INN: DEXAMETHASONE Trade Name: Prednisolone 1mg Tablets INN or Proposed INN: Prednisolone Other descriptive name: PREDNISOLONE | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 8 | EUCTR2015-003996-32-FR (EUCTR) | 03/11/2015 | 04/12/2015 | Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study | Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study - PRENATAL DEX | Patient with Congenital Adrenal Hyperplasia (CAH) or sibling of a CAH patient . Patient no connection with Congenital Adrenal Hyperplasia MedDRA version: 18.1;Level: PT;Classification code 10061630;Term: Adrenogenital syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Dectancyl | Hospices Civils de Lyon | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 9 | NCT00621985 (ClinicalTrials.gov) | April 2008 | 11/2/2008 | Dexamethasone Treatment of Congenital Adrenal Hyperplasia | Dexamethasone Treatment of Congenital Adrenal Hyperplasia | Adrenal Hyperplasia, Congenital | Drug: dexamethasone;Drug: Hydrocortisone | Boston Children’s Hospital | NULL | Completed | 2 Years | 9 Years | All | 5 | Phase 2 | United States |