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 87 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 |
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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 | Withdrawn | 2 Years | 9 Years | All | 0 | Phase 2 | United States |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 | NCT05669950 (ClinicalTrials.gov) | December 19, 2022 | 20/12/2022 | Study of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia | A Multi-site, Open-label, Sequential-group, Multiple-ascending-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Lu AG13909 in Patients With Congenital Adrenal Hyperplasia A Multi-site, Open-label, Sequential-group, Multiple-ascending-dose Study to Investigate the Safety, ... | Congenital Adrenal Hyperplasia | Drug: Lu AG13909 | H. Lundbeck A/S | NULL | Recruiting | 18 Years | 55 Years | All | 12 | Phase 1 | United Kingdom |
3 | NCT05299554 (ClinicalTrials.gov) | April 1, 2022 | 5/1/2022 | Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperp ... | A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort ... | Congenital Adrenal Hyperplasia | Drug: Chronocort | Diurnal Limited | NULL | Enrolling by invitation | 16 Years | N/A | All | 181 | Phase 3 | United States;France |
4 | 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 | ||
5 | 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 |
6 | EUCTR2020-004381-19-DE (EUCTR) | 16/12/2021 | 09/04/2021 | Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congeni ... | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecer ... | Classic Congenital Adrenal Hyperplasia (CAH) MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Classic Congenital Adrenal Hyperplasia(CAH) MedDRA version: 20.0;Level: LLT;Classification code 1001 ... | Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont Product Name: Crin ... | Neurocrine Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 3 | France;United States;Greece;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy;Sweden | ||
7 | 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 Hydrocortisone Replacement Therapy in Participants Aged 16 ... | 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 |
8 | NCT05128942 (ClinicalTrials.gov) | December 10, 2021 | 27/10/2021 | A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children With CAH | A Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of SPR001 (Tildacerfont) in Children Aged 2 to 17 Years With Congenital Adrenal Hyperplasia A Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of SPR001 (Tildacerfont) in Ch ... | Congenital Adrenal Hyperplasia;21-OHD | Drug: Tildacerfont | Spruce Biosciences | NULL | Recruiting | 2 Years | 17 Years | All | 20 | Phase 2 | United States |
9 | EUCTR2020-004381-19-IT (EUCTR) | 13/10/2021 | 30/08/2021 | Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congeni ... | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment - n/a A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecer ... | Congenital adrenal hyperplasia (CAH) is a group of rare inherited endocrine disorders characterized by a deficiency of one of the enzymes needed to make specific hormones. 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 a group of rare inherited endocrine disorders characterized b ... | Product Name: Crinecerfont Product Code: [NBI-74788] Other descriptive name: Crinecerfont is a novel non-peptide selective corticotropin releasing factor 1 (CRF1 ) receptor antagonist. Product Name: Crinecerfont Product Code: [NBI-74788] Other descriptive name: Crinecerfont is a novel non-peptide selective corticotropin releasing factor 1 (CRF1 ) receptor antagonist. Product Name: Crinecerfont Product Code: [NBI-74788] Other descriptive name: Crinecerfontis a novel no ... | Neurocrine Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | France;United States;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden | ||
10 | EUCTR2020-004381-19-ES (EUCTR) | 13/08/2021 | 13/08/2021 | Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congeni ... | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecer ... | Classic Congenital Adrenal Hyperplasia (CAH) MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19] Classic Congenital Adrenal Hyperplasia(CAH) MedDRA version: 20.0;Level: LLT;Classification code 1001 ... | Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont Product Name: Crin ... | Neurocrine Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 3 | France;United States;Greece;Canada;Poland;Belgium;Spain;Germany;Italy;Sweden |