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 : 88 / 薬物数 : 90 - (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 | 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. | 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 | 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] | 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 | 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 | ||
| 2 | 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 | Congenital Adrenal Hyperplasia;21-OHD | Drug: Tildacerfont | Spruce Biosciences | NULL | Not yet recruiting | 6 Years | 17 Years | All | 20 | Phase 2 | NULL |
| 3 | EUCTR2019-004765-40-PL (EUCTR) | 24/02/2021 | 30/09/2020 | This is a randomized, double-blinded, Placebo controlled trial that will evaluate the potential of tildacerfont to reduce GC use in adult subjects with classic CAH who are on supraphysiologic doses of GC therapy. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 4 | EUCTR2019-004764-22-PL (EUCTR) | 08/02/2021 | 24/09/2020 | 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 | 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 - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 5 | EUCTR2019-004764-22-GB (EUCTR) | 23/12/2020 | 09/07/2020 | 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 | 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 - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | Sweden;United Kingdom;Germany;Netherlands;Denmark;Poland;Spain;France;United States | ||
| 6 | EUCTR2019-004765-40-NL (EUCTR) | 10/12/2020 | 16/09/2020 | This is a randomized, double-blinded, Placebo controlled trial that will evaluate the potential of tildacerfont to reduce GC use in adult subjects with classic CAH who are on supraphysiologic doses of GC therapy. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;United States;Canada;Poland;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Sweden | ||
| 7 | EUCTR2019-004765-40-DE (EUCTR) | 20/11/2020 | 18/09/2020 | This is a randomized, double-blinded, Placebo controlled trial that will evaluate the potential of tildacerfont to reduce GC use in adult subjects with classic CAH who are on supraphysiologic doses of GC therapy. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Sweden | ||
| 8 | EUCTR2019-004765-40-DK (EUCTR) | 17/11/2020 | 16/09/2020 | This is a randomized, double-blinded, Placebo controlled trial that will evaluate the potential of tildacerfont to reduce GC use in adult subjects with classic CAH who are on supraphysiologic doses of GC therapy. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;United States;Canada;Poland;Spain;Australia;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 9 | EUCTR2019-004764-22-DK (EUCTR) | 17/11/2020 | 09/07/2020 | 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 70 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baseline | 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 - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | France;United States;Canada;Poland;Spain;Australia;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 10 | EUCTR2019-004765-40-SE (EUCTR) | 03/11/2020 | 18/09/2020 | This is a randomized, double-blinded, Placebo controlled trial that will evaluate the potential of tildacerfont to reduce GC use in adult subjects with classic CAH who are on supraphysiologic doses of GC therapy. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | France;United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Sweden | ||
| 11 | EUCTR2019-004764-22-NL (EUCTR) | 15/10/2020 | 01/07/2020 | 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 70 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baseline | 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 - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | France;United States;Canada;Poland;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Sweden | ||
| 12 | EUCTR2019-004764-22-DE (EUCTR) | 08/10/2020 | 08/07/2020 | 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 70 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baseline | 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 - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | France;United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Sweden | ||
| 13 | NCT04544410 (ClinicalTrials.gov) | September 29, 2020 | 30/8/2020 | A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects With Classic Congenital Adrenal Hyperplasia | Congenital Adrenal Hyperplasia | Drug: Tildacerfont/Placebo | Spruce Biosciences | NULL | Recruiting | 18 Years | N/A | All | 90 | Phase 2 | United States;Australia;Canada;Denmark;Germany;Netherlands;Spain;Sweden |
| 14 | NCT04457336 (ClinicalTrials.gov) | August 26, 2020 | 25/6/2020 | A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH | 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 | Congenital Adrenal Hyperplasia | Drug: Tildacerfont/Placebo | Spruce Biosciences | NULL | Recruiting | 18 Years | N/A | All | 72 | Phase 2 | United States;Australia;Canada;Denmark;Germany;Netherlands;Spain;Sweden |
| 15 | EUCTR2019-004764-22-SE (EUCTR) | 26/08/2020 | 08/07/2020 | 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 70 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baseline | 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 - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia | Classic Congenital Adrenal Hyperplasia MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: Tildacerfont Product Code: SPR001 INN or Proposed INN: TILDACERFONT | Spruce Biosciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | France;United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Sweden | ||
| 16 | NCT03687242 (ClinicalTrials.gov) | September 6, 2018 | 11/9/2018 | Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia | A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia | Congenital Adrenal Hyperplasia;CAH - Congenital Adrenal Hyperplasia;CAH - 21-Hydroxylase Deficiency | Drug: SPR001 | Spruce Biosciences | NULL | Completed | 18 Years | N/A | All | 11 | Phase 2 | United States |
| 17 | NCT03257462 (ClinicalTrials.gov) | July 26, 2017 | 15/8/2017 | Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia | A Phase 2, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Efficacy of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia (CAH) | Congenital Adrenal Hyperplasia;CAH - Congenital Adrenal Hyperplasia | Drug: SPR001 | Spruce Biosciences | NULL | Completed | 18 Years | N/A | All | 26 | Phase 2 | United States |