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 | 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 | 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 | 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] | Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont | 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 | ||
| 2 | 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 | 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 | 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] | 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. | 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 | ||
| 3 | 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 | 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 | 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] | Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont 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 | 81 | Phase 3 | France;United States;Greece;Canada;Poland;Belgium;Spain;Germany;Italy;Sweden | ||
| 4 | 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 (CAHTALYST) | 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] | 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 | Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Germany;Sweden | ||
| 5 | NCT04806451 (ClinicalTrials.gov) | June 24, 2021 | 16/3/2021 | Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study) | 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 | Congenital Adrenal Hyperplasia | Drug: Crinecerfont;Drug: Placebo | Neurocrine Biosciences | NULL | Active, not recruiting | 2 Years | 17 Years | All | 103 | Phase 3 | United States;Belgium;Canada;France;Germany;Greece;Italy;Poland;Spain;United Kingdom |
| 6 | EUCTR2020-004381-19-FR (EUCTR) | 23/06/2021 | 21/04/2021 | Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia | 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 | 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] | Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont 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 | 81 | Phase 3 | United States;France;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden | ||
| 7 | EUCTR2020-004381-19-GR (EUCTR) | 07/06/2021 | 06/04/2021 | Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia | 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 | 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] | Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont 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 | 81 | Phase 3 | France;United States;Canada;Greece;Spain;Poland;Belgium;Germany;Italy;Sweden | ||
| 8 | EUCTR2019-004873-17-AT (EUCTR) | 17/02/2021 | 07/10/2020 | 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 | 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] | 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 | Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden | ||
| 9 | EUCTR2019-004873-17-DE (EUCTR) | 15/01/2021 | 19/05/2020 | 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 | 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] | 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 | Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden;Czech Republic;Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France | ||
| 10 | EUCTR2019-004873-17-BG (EUCTR) | 17/12/2020 | 03/07/2020 | 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 | 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] | 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;Germany;Netherlands;Sweden | ||
| 11 | EUCTR2019-004873-17-IT (EUCTR) | 16/12/2020 | 24/05/2021 | 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 - n/a | 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] | Product Name: Crinecerfont Product Code: [NBI-74788] Other descriptive name: Crinecerfont is a novel non-peptide selective corticotropin releasing factor 1 (CRF1 ) receptor antagonist. | Neurocrine Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 165 | Phase 3 | Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden;United States;Portugal;Czechia | ||
| 12 | EUCTR2019-004873-17-CZ (EUCTR) | 07/12/2020 | 22/05/2020 | 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 | 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] | 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 | Serbia;Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden | ||
| 13 | EUCTR2019-004873-17-PL (EUCTR) | 01/12/2020 | 03/07/2020 | 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 | 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] | 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 | Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Germany;Sweden | ||
| 14 | EUCTR2019-004873-17-GB (EUCTR) | 15/10/2020 | 30/04/2020 | 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 | 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] | 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;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden | ||
| 15 | EUCTR2019-004873-17-PT (EUCTR) | 12/10/2020 | 30/06/2020 | 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 | 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] | 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 | Portugal;United States;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden | ||
| 16 | EUCTR2019-004873-17-GR (EUCTR) | 29/07/2020 | 30/07/2020 | 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 | 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] | 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 | Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Germany;Sweden | ||
| 17 | NCT04490915 (ClinicalTrials.gov) | July 23, 2020 | 24/7/2020 | Global Safety and Efficacy Registration Study of Crinecerfont for 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 | Congenital Adrenal Hyperplasia | Drug: Crinecerfont;Drug: Placebo | Neurocrine Biosciences | NULL | Active, not recruiting | 18 Years | N/A | All | 182 | Phase 3 | United States;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Portugal;Serbia;Spain;Sweden;United Kingdom |
| 18 | NCT03525886 (ClinicalTrials.gov) | April 10, 2018 | 2/5/2018 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia | A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects With Congenital Adrenal Hyperplasia | CAH - Congenital Adrenal Hyperplasia | Drug: NBI-74788 | Neurocrine Biosciences | NULL | Completed | 18 Years | 50 Years | All | 18 | Phase 2 | United States |
| 19 | EUCTR2020-004381-19-BE (EUCTR) | 25/06/2021 | Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia | 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 | 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] | Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont | Neurocrine Biosciences, Inc. | NULL | NA | Female: yes Male: yes | 81 | Phase 3 | France;United States;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden | |||
| 20 | EUCTR2020-004381-19-PL (EUCTR) | 10/05/2021 | Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia | 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 | 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] | Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont Product Name: Crinecerfont Product Code: NBI-74788 INN or Proposed INN: Crinecerfont | Neurocrine Biosciences, Inc. | NULL | NA | Female: yes Male: yes | 81 | Phase 3 | United States;France;Greece;Canada;Spain;Belgium;Poland;Germany;Italy;Sweden |