81. Congenital adrenal hyperplasia Clinical trials / Disease details
Clinical trials : 88 / Drugs : 90 - (DrugBank : 23) / Drug target genes : 12 - Drug target pathways : 68
Showing 1 to 10 of 88 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 ... | Not yet recruiting | 2 Years | 9 Years | All | 54 | 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 ... | 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 Randomized, Double-Blind, Active-Controlled, Phase 3 Study ofChronocort Compared with Immediate-Rele ... | 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 a 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 | 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 | 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 | ||
| 5 | NCT05128942 (ClinicalTrials.gov) | December 2021 | 27/10/2021 | A Phase 2 Study to Evaluate the Safety, PK, and Exploratory PD of Tildacerfont in Children With CAH | A Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of SPR001 (Tildacerfont) in Children Aged 6 to 17 Years With Congenital Adrenal Hyperplasia A Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of SPR001 ... | Congenital Adrenal Hyperplasia;21-OHD | Drug: Tildacerfont | Spruce Biosciences | NULL | Not yet recruiting | 6 Years | 17 Years | All | 20 | Phase 2 | NULL |
| 6 | NCT05063994 (ClinicalTrials.gov) | November 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 | Not yet recruiting | 16 Years | N/A | All | 150 | Phase 3 | United States |
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | EUCTR2019-004873-17-NL (EUCTR) | 20/07/2021 | 12/11/2020 | A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal Hyperplasia | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult 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 | Neurocrine Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | United States;Portugal;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden United States;Portugal;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgi ... | ||
| 10 | NCT04783181 (ClinicalTrials.gov) | July 1, 2021 | 1/3/2021 | A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH) | A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of the Safety and Efficacy of Gene Therapy for Congenital Adrenal Hyperplasia Through Administration of an Adeno-Associated Virus (AAV) Serotype 5-Based Recombinant Vector Encoding the Human CYP21A2 Gene A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of the Safety and Efficacy of Gene Th ... | Congenital Adrenal Hyperplasia | Biological: AAV BBP-631 | Adrenas Therapeutics Inc | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 1/Phase 2 | United States;Australia |