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
Showing 1 to 10 of 32 diseases
| 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 | NCT03548246 (ClinicalTrials.gov) | January 2023 | 24/4/2015 | Androgen Reduction in Congenital Adrenal Hyperplasia | A Phase 1-2 Multi-Center Study to Assess the Efficacy and Safety of Abiraterone Acetate as Adjunctive Therapy in Pre-Pubescent Children With Classic 21-Hydroxylase Deficiency A Phase 1-2 Multi-Center Study to Assess the Efficacy and Safety of Abiraterone Acetate as Adjunctiv ... | Congenital Adrenal Hyperplasia | Drug: Abiraterone acetate;Drug: Placebo;Drug: Hydrocortisone;Drug: Fludrocortisone | University of Texas Southwestern Medical Center | National Institutes of Health Clinical Center (CC);University of Michigan;Children's Hospital Los Angeles;Feinstein Institute for Medical Research National Institutes of Health Clinical Center (CC);University of Michigan;Children's Hospital Los An ... | Withdrawn | 2 Years | 9 Years | All | 0 | Phase 2 | United States |
| 2 | EUCTR2019-004764-22-IT (EUCTR) | 12/01/2022 | 07/10/2021 | This is a randomized, double-blinded, Placebo controlled trial with a 3-part treatment period that will evaluate the efficacy and safety of up to 52 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baseline. This is a randomized, double-blinded, Placebo controlled trial with a 3-part treatment period that w ... | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Study to Evaluate Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adre A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safe ... | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850 MedDRA version: 20.0;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323; ... | Product Name: Tildacerfont Product Code: [SPR001] INN or Proposed INN: TILDACERFONT Trade Name: HYDROCORTISONE- hydrocortisone tablet Product Name: HYDROCORTISONE- hydrocortisone tablet Product Code: [National Drug Code: 59762-0074] INN or Proposed INN: IDROCORTISONE Other descriptive name: HYDROCORTISONE Product Name: Tildacerfont Product Code: [SPR001] INN or Proposed INN: TILDACERFONT Trade Name: HYDROCO ... | Spruce Biosciences Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 3 | JPRN-jRCT2031210491 | 04/01/2022 | 17/12/2021 | Double-blind comparison of Chronocort versus standard hydrocortisonereplacement therapy in participants aged 16 years and over with congenital adrenalhyperplasia Double-blind comparison of Chronocort versus standard hydrocortisonereplacement therapy in participa ... | A randomized, Double-Blind, Active-Controlled, Phase 3 Study ofChronocort Compared with Immediate-Release Hydrocortisone Replacement Therapy inParticipants Aged 16 Years and Over with Congenital Adrenal Hyperplasia A randomized, Double-Blind, Active-Controlled, Phase 3 Study ofChronocort Compared with Immediate-Re ... | Congenital adrenal hyperplasia (CAH) | Participants randomized to Chronocort will receive 10 mg Chronocort in the morning on waking (typically between 06:00 and 08:00), placebo in the afternoon (between 15:00 and 17:00) and 20 mg Chronocort at night just prior to going to bed (typically between 22:00 and midnight). A maximum of 3 dose reductions will be allowed, resulting in a minimum final dose of 15 mg a day. Participants randomized to immediate-release hydrocortisone (IRHC) will receive 20 mg IRHC in the morning on waking (typically between 06:00 and 08:00), 10 mg IRHC in the afternoon (between 15:00 and 17:00) and placebo at night just prior to going to bed (typically between 22:00 and midnight). A maximum of 3 dose reductions will be allowed, resulting in a minimum final dose of 15 mg a day. The dose for both groups will be adjusted by an Independent blinded physician based on the androgen levels and adrenal function at Weeks 4, 10, and 16. At Week 16 the dose will be fixed and should remain unchanged. The blinded titrator can complete a dose increase at week 32 of 5 mg based on androgen results and adrenal function. Additionally, if a participant shows persistent signs of under replacement the Investigator can request 1 dose reversion of 5 mg, this will be discussed and agreed by the medical monitor. Participants randomized to Chronocort will receive 10 mg Chronocort in the morning on waking (typica ... | Fujii Katsuya | NULL | Recruiting | >= 16age old | Not applicable | Both | 15 | Phase 2 | US;France;Turkey;Japan |
| 4 | NCT05063994 (ClinicalTrials.gov) | December 13, 2021 | 28/5/2021 | Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia Comparison of Chronocort Versus Standard HydrocortisoneReplacement Therapy in Participants Aged 16 Y ... | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared With Immediate-R ... | Congenital Adrenal Hyperplasia | Drug: Chronocort;Drug: Cortef | Diurnal Limited | NULL | Recruiting | 16 Years | N/A | All | 150 | Phase 3 | United States;France;Japan |
| 5 | 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 Patient ... | 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 Patient ... | 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 |
| 6 | EUCTR2018-004802-24-NL (EUCTR) | 20/05/2019 | 13/05/2019 | Avoiding over and undertreatment by optimizing of the timing ofglucocorticoïd treatment in children with cnogenital adrenal hyperplasia Avoiding over and undertreatment by optimizing of the timing ofglucocorticoïd treatment in children ... | Optimizing timing of glucocorticoid treatment in children with congenitaladrenal hyperplasia - OPTIMED study Optimizing timing of glucocorticoid treatment in children with congenitaladrenal hyperplasia - OPTIM ... | Congenital adrenal hyperplasia (CAH) is a disorder of adrenal steroidsynthesis leading to cortisol deficiency and an increase in androgenproduction.Treatment in children consists of hydrocortisone substitutionthereby also restoring the negative feedback on the pituitary gland andconsequently normalize androgen production. There is still no evidenceabout the best timing of hydrocortisone use: The highest dosage ofhydrocortisone in the morning or the highest dosage at night;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Congenital adrenal hyperplasia (CAH) is a disorder of adrenal steroidsynthesis leading to cortisolde ... | Product Name: Hydrocortisone INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISONE Product Name: Hydrocortisone INN or Proposed INN: Hydrocortisone Other descriptive name: HYDROCORTISON ... | Radboud University Nijmegen Medical Centre | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Netherlands | ||
| 7 | EUCTR2015-005448-32-DK (EUCTR) | 01/09/2017 | 28/06/2017 | The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy. The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evalua ... | A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of ... | 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] Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of ... | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive ... | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 8 | EUCTR2015-005448-32-SE (EUCTR) | 09/02/2017 | 06/09/2016 | The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy. The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evalua ... | A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of ... | 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] Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of ... | Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive ... | Diurnal Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 138 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (P ... | France;United States;Denmark;Germany;United Kingdom;Sweden | ||
| 9 | EUCTR2015-005448-32-DE (EUCTR) | 31/01/2017 | 02/11/2016 | The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evaluate the long-term safety of Chronocort® and also its long term efficacy. The proposed study aims to build on the results of clinical studies DIUR-003 and DIUR-005 and evalua ... | A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of ... | 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] Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of ... | Product Name: Chronocort® 5 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® 10 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® 20 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive name: Cortisol Product Name: Chronocort® 5 mg Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descri ... | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 136 | Phase 3 | United States;France;Denmark;Germany;United Kingdom;Sweden | ||
| 10 | 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. Chronocort®, a slow release medicinal preparation of hydrocortisone, will be compared with currently ... | A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucoco ... | 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] Congenital adrenal hyperplasia (CAH); is generally due to 21-hydroxylase deficiency, is a disease of ... | 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 Product Name: Chronocort® Product Code: DIURF-006 INN or Proposed INN: HYDROCORTISONE Other descriptive ... | Diurnal Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden |