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

  
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PhaseCountries
1NCT03548246
(ClinicalTrials.gov)
January 202324/4/2015Androgen Reduction in Congenital Adrenal HyperplasiaA 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 DeficiencyCongenital Adrenal HyperplasiaDrug: Abiraterone acetate;Drug: Placebo;Drug: Hydrocortisone;Drug: FludrocortisoneUniversity of Texas Southwestern Medical CenterNational Institutes of Health Clinical Center (CC);University of Michigan;Children's Hospital Los Angeles;Feinstein Institute for Medical ResearchNot yet recruiting2 Years9 YearsAll54Phase 2United States
2EUCTR2019-004764-22-IT
(EUCTR)
12/01/202207/10/2021This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
3JPRN-jRCT2031210491
04/01/202217/12/2021Double-blind comparison of Chronocort versus standard hydrocortisonereplacement therapy in participants aged 16 years and over with congenital adrenalhyperplasiaRandomized, 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 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.
Fujii KatsuyaNULLRecruiting>= 16age oldNot applicableBoth15Phase 2US;France;Turkey;Japan
4EUCTR2020-004381-19-DE
(EUCTR)
16/12/202109/04/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3France;United States;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden
5NCT05128942
(ClinicalTrials.gov)
December 202127/10/2021A Phase 2 Study to Evaluate the Safety, PK, and Exploratory PD of Tildacerfont in Children With CAHA Phase 2 Study to Evaluate the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of SPR001 (Tildacerfont) in Children Aged 6 to 17 Years With Congenital Adrenal HyperplasiaCongenital Adrenal Hyperplasia;21-OHDDrug: TildacerfontSpruce BiosciencesNULLNot yet recruiting6 Years17 YearsAll20Phase 2NULL
6NCT05063994
(ClinicalTrials.gov)
November 202128/5/2021Comparison of Chronocort Versus Standard Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over With Congenital Adrenal HyperplasiaA 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 HyperplasiaCongenital Adrenal HyperplasiaDrug: Chronocort;Drug: CortefDiurnal LimitedNULLNot yet recruiting16 YearsN/AAll150Phase 3United States
7EUCTR2020-004381-19-IT
(EUCTR)
13/10/202130/08/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3France;United States;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden
8EUCTR2020-004381-19-ES
(EUCTR)
13/08/202113/08/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3France;United States;Greece;Canada;Poland;Belgium;Spain;Germany;Italy;Sweden
9EUCTR2019-004873-17-NL
(EUCTR)
20/07/202112/11/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden
10NCT04783181
(ClinicalTrials.gov)
July 1, 20211/3/2021A 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 GeneCongenital Adrenal HyperplasiaBiological: AAV BBP-631Adrenas Therapeutics IncNULLRecruiting18 YearsN/AAll25Phase 1/Phase 2United States;Australia
11NCT04806451
(ClinicalTrials.gov)
June 24, 202116/3/2021Global 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 TreatmentCongenital Adrenal HyperplasiaDrug: Crinecerfont;Drug: PlaceboNeurocrine BiosciencesNULLRecruiting2 Years17 YearsAll81Phase 3United States;Canada;France;Greece;Poland
12EUCTR2020-004381-19-FR
(EUCTR)
23/06/202121/04/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3United States;France;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden
13EUCTR2020-004381-19-GR
(EUCTR)
07/06/202106/04/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3France;United States;Canada;Greece;Spain;Poland;Belgium;Germany;Italy;Sweden
14EUCTR2019-004765-40-PL
(EUCTR)
24/02/202130/09/2020This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden
15EUCTR2019-004873-17-AT
(EUCTR)
17/02/202107/10/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden
16EUCTR2019-004764-22-PL
(EUCTR)
08/02/202124/09/2020This 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 baselineA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden
17EUCTR2019-004873-17-DE
(EUCTR)
15/01/202119/05/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Czechia;Greece;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden
18EUCTR2019-004764-22-GB
(EUCTR)
23/12/202009/07/2020This 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 baselineA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2Sweden;United Kingdom;Germany;Netherlands;Denmark;Poland;Spain;France;United States
19EUCTR2019-004873-17-BG
(EUCTR)
17/12/202003/07/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden
20EUCTR2019-004873-17-IT
(EUCTR)
16/12/202024/05/2021A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden;United States;Portugal;Czechia
21EUCTR2019-004765-40-NL
(EUCTR)
10/12/202016/09/2020This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;United States;Canada;Poland;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Sweden
22EUCTR2019-004873-17-CZ
(EUCTR)
07/12/202022/05/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Serbia;Portugal;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden
23EUCTR2019-004873-17-PL
(EUCTR)
01/12/202003/07/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Netherlands;Sweden
24EUCTR2019-004765-40-DE
(EUCTR)
20/11/202018/09/2020This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Sweden
25EUCTR2019-004764-22-DK
(EUCTR)
17/11/202009/07/2020This 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 baselineA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2France;United States;Canada;Poland;Spain;Australia;Denmark;Netherlands;Germany;United Kingdom;Sweden
26EUCTR2019-004765-40-DK
(EUCTR)
17/11/202016/09/2020This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;United States;Canada;Poland;Spain;Australia;Denmark;Netherlands;Germany;United Kingdom;Sweden
27EUCTR2019-004765-40-SE
(EUCTR)
03/11/202018/09/2020This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2France;United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Sweden
28EUCTR2019-004764-22-NL
(EUCTR)
15/10/202001/07/2020This 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 baselineA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2France;United States;Canada;Poland;Spain;Denmark;Australia;Germany;Netherlands;United Kingdom;Sweden
29EUCTR2019-004873-17-GB
(EUCTR)
15/10/202030/04/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden
30EUCTR2019-004873-17-PT
(EUCTR)
12/10/202030/06/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden
31EUCTR2019-004764-22-DE
(EUCTR)
08/10/202008/07/2020This 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 baselineA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2France;United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Sweden
32NCT04536662
(ClinicalTrials.gov)
October 1, 202023/8/2020Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase DeficiencyComparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21a-hydroxylase DeficiencyCongenital Adrenal HyperplasiaDrug: Hydrocortisone;Drug: Prednisone;Drug: DexamethasoneShanghai Jiao Tong University School of MedicineNULLNot yet recruiting14 Years45 YearsAll120Phase 4China
33NCT04544410
(ClinicalTrials.gov)
September 29, 202030/8/2020A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAHA 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 HyperplasiaCongenital Adrenal HyperplasiaDrug: Tildacerfont/PlaceboSpruce BiosciencesNULLRecruiting18 YearsN/AAll90Phase 2United States;Australia;Canada;Denmark;Germany;Netherlands;Spain;Sweden
34EUCTR2019-004764-22-SE
(EUCTR)
26/08/202008/07/2020This 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 baselineA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2France;United States;Canada;Poland;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Sweden
35NCT04457336
(ClinicalTrials.gov)
August 26, 202025/6/2020A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAHA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects With Classic Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: Tildacerfont/PlaceboSpruce BiosciencesNULLRecruiting18 YearsN/AAll72Phase 2United States;Australia;Canada;Denmark;Germany;Netherlands;Spain;Sweden
36EUCTR2019-004873-17-GR
(EUCTR)
29/07/202030/07/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Germany;Sweden
37NCT04490915
(ClinicalTrials.gov)
July 23, 202024/7/2020Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal HyperplasiaA 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 TreatmentCongenital Adrenal HyperplasiaDrug: Crinecerfont;Drug: PlaceboNeurocrine BiosciencesNULLRecruiting18 YearsN/AAll165Phase 3United States;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Poland;Portugal;Spain;Sweden;United Kingdom
38NCT04045145
(ClinicalTrials.gov)
September 11, 201931/7/2019Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects With Congenital Adrenal HyperplasiaA Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects With Congenital Adrenal HyperplasiaCAH - Congenital Adrenal HyperplasiaDrug: NBI-74788Neurocrine BiosciencesNULLCompleted14 Years17 YearsAll8Phase 2United States
39EUCTR2018-004802-24-NL
(EUCTR)
20/05/201913/05/2019Avoiding over and undertreatment by optimizing of the timing ofglucocorticoïd treatment in children with cnogenital adrenal hyperplasiaOptimizing timing of glucocorticoid treatment in children with congenitaladrenal hyperplasia - OPTIMED study 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]Product Name: Hydrocortisone
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Radboud University Nijmegen Medical CentreNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Netherlands
40NCT03718234
(ClinicalTrials.gov)
January 1, 201911/10/2018Subcutaneous Hydrocortisone Children With Congenital Adrenal HyperplasiaInterval Bolus Delivery of Subcutaneous Hydrocortisone Via Infusion Pump in Children With Congenital Adrenal HyperplasiaCongenital Adrenal Hyperplasia;Hyperplasia;Adrenal Hyperplasia;Congenital Disorders;Adrenocortical Hyperfunction;Disorders of Sex Development;Urogenital Abnormalities;Genetic Diseases, Inborn;Steroid Metabolic Diseases, Inborn;Adrenal Gland Disease;HydrocortisoneDrug: Subcutaneous hydrocortisone;Drug: Standard glucocorticoid therapyUniversity of MinnesotaNULLRecruiting4 Years18 YearsAll8Phase 1United States
41NCT03532022
(ClinicalTrials.gov)
October 4, 201818/4/2018Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement TherapyAn Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: Chronocort®;Drug: Standard CareDiurnal LimitedNational Institutes of Health (NIH)Terminated16 YearsN/AAll2Phase 3United States
42EUCTR2017-004878-34-FR
(EUCTR)
18/09/201824/04/2018A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal HyperplasiaA Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of 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: Diseases [C] - Hormonal diseases [C19]
Product Name: Nevanimibe Hydrochloride
Product Code: ATR-101
INN or Proposed INN: Nevanimibe hydrochloride
Other descriptive name: CI-984, 17AA70, PD 132301-2
Millendo Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2France;Spain;Brazil;Israel
43NCT03687242
(ClinicalTrials.gov)
September 6, 201811/9/2018Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal HyperplasiaA 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal HyperplasiaCongenital Adrenal Hyperplasia;CAH - Congenital Adrenal Hyperplasia;CAH - 21-Hydroxylase DeficiencyDrug: SPR001Spruce BiosciencesNULLCompleted18 YearsN/AAll11Phase 2United States
44EUCTR2017-004878-34-ES
(EUCTR)
01/08/201821/05/2018A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal HyperplasiaA Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of 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: Diseases [C] - Hormonal diseases [C19]
Product Name: Nevanimibe Hydrochloride
Product Code: ATR-101
INN or Proposed INN: Nevanimibe hydrochloride
Other descriptive name: CI-984, 17AA70, PD 132301-2
Millendo Therapeutics US, Inc.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2France;Brazil;Spain;Israel
45NCT03669549
(ClinicalTrials.gov)
July 11, 201810/9/2018Nevanimibe HCl for the Treatment of Classic CAHA Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: Nevanimibe hydrochlorideMillendo Therapeutics US, Inc.NULLTerminated18 Years80 YearsAll15Phase 2Brazil;Czechia;France;Israel;Spain
46NCT03525886
(ClinicalTrials.gov)
April 10, 20182/5/2018Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal HyperplasiaA Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects With Congenital Adrenal HyperplasiaCAH - Congenital Adrenal HyperplasiaDrug: NBI-74788Neurocrine BiosciencesNULLCompleted18 Years50 YearsAll18Phase 2United States
47EUCTR2015-005448-32-DK
(EUCTR)
01/09/201728/06/2017The 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.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) 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]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
48NCT02574910
(ClinicalTrials.gov)
August 1, 201724/4/2015Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1A Phase 1 Multi-Center Study to Assess the Efficacy and Safety of Abiraterone Acetate as Adjunctive Therapy in Pre-Pubescent Children With Classic 21-Hydroxylase DeficiencyCongenital Adrenal HyperplasiaDrug: Abiraterone acetateUniversity of Texas Southwestern Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);University of Michigan;Children's Hospital Los AngelesActive, not recruiting2 Years9 YearsAll36Phase 1United States
49NCT03257462
(ClinicalTrials.gov)
July 26, 201715/8/2017Study of SPR001 in Adults With Classic Congenital Adrenal HyperplasiaA 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 HyperplasiaDrug: SPR001Spruce BiosciencesNULLCompleted18 YearsN/AAll26Phase 2United States
50EUCTR2015-005448-32-SE
(EUCTR)
09/02/201706/09/2016The 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.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) 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]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Diurnal LtdNULLAuthorised-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): noFrance;United States;Denmark;Germany;United Kingdom;Sweden
51EUCTR2015-005448-32-DE
(EUCTR)
31/01/201702/11/2016The 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.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia 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]
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
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3United States;France;Denmark;Germany;United Kingdom;Sweden
52EUCTR2015-000711-40-DK
(EUCTR)
08/09/201611/07/2016Chronocort®, 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.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. 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]
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
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
53NCT03062280
(ClinicalTrials.gov)
August 18, 201622/8/2016A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAHA Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort® in the Treatment of Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: HydrocortisoneDiurnal LimitedNULLActive, not recruiting18 YearsN/AAll92Phase 3United States
54NCT03760835
(ClinicalTrials.gov)
August 11, 20169/11/2018Congenital Adrenal Hyperplasia Once Daily Hydrocortisone TreatmentCongenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone TreatmentCongenital Adrenal HyperplasiaDrug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone);Drug: Dual release hydrocortisone (plenadren)Federico II UniversityNULLRecruiting18 YearsN/AAll150Phase 4Italy
55EUCTR2015-005448-32-GB
(EUCTR)
20/07/201605/07/2016The 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.A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH) 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]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Diurnal LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
136Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
56EUCTR2015-000711-40-DE
(EUCTR)
23/05/201606/10/2015Chronocort®, 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.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. 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]
Product Name: Chronocort® 5 mg
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Product Name: Hydrocortisone 10mg Tablet
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Product Name: Dexamethasone 0.5mg Tablet
INN or Proposed INN: DEXAMETHASONE
Product Name: Prednisolone 5mg Tablet
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Product Name: Chronocort® 10 mg
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Product Name: Chronocort® 20 mg
Diurnal LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
57NCT02804178
(ClinicalTrials.gov)
May 18, 20161/6/2016A Study of ATR-101 for the Treatment of Congenital Adrenal HyperplasiaA Phase 2, Multicenter Study of ATR-101 for the Treatment of Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: ATR-101Millendo Therapeutics, Inc.NULLCompleted18 Years80 YearsAll10Phase 2United States
58EUCTR2015-000711-40-NL
(EUCTR)
28/04/201617/11/2015Chronocort®, 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.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. 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: 18.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 20mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 1,5 mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 5 mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
110Phase 3United States;Denmark;Germany;Netherlands;United Kingdom;Sweden
59NCT02733367
(ClinicalTrials.gov)
March 4, 201616/3/2016Extension Study for Patients Entered Into Study Infacort 003Open-label, Long-term Follow-up of Safety and Biochemical Disease Control of Infacort® in Neonates, Infants and Children With Congenital Adrenal Hyperplasia and Adrenal Insufficiency Previously Enrolled in the Infacort 003 StudyAdrenal InsufficiencyDrug: Infacort®Diurnal LimitedNULLCompleted1 Month6 YearsAll18Phase 3Germany
60NCT02716818
(ClinicalTrials.gov)
February 22, 201626/2/2016Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal HyperplasiaA Phase III Study of Efficacy, Safety and Tolerability of Chronocort® Compared With Standard Glucocorticoid Replacement Therapy in the Treatment of Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: Chronocort®;Drug: standard glucocorticoid therapyDiurnal LimitedNULLCompleted18 YearsN/AAll122Phase 3United States
61EUCTR2015-000711-40-SE
(EUCTR)
11/01/201613/10/2015Chronocort®, 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.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. 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]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 20mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 2mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 1mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Diurnal LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
62EUCTR2015-000711-40-GB
(EUCTR)
19/11/201528/07/2015Chronocort®, 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.A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia. 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]
Product Name: Chronocort®
Product Code: DIURF-006
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: Cortisol
Trade Name: Hydrocortisone 20mg Tablets
INN or Proposed INN: Hydrocortisone
Other descriptive name: HYDROCORTISONE
Trade Name: Dexamethasone 2mg Tablets
INN or Proposed INN: DEXAMETHASONE
Trade Name: Prednisolone 1mg Tablets
INN or Proposed INN: Prednisolone
Other descriptive name: PREDNISOLONE
Diurnal LtdNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
63EUCTR2015-003996-32-FR
(EUCTR)
03/11/201504/12/2015Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX StudyMulticentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study - PRENATAL DEX Patient with Congenital Adrenal Hyperplasia (CAH) or sibling of a CAH patient . Patient no connection with Congenital Adrenal Hyperplasia
MedDRA version: 18.1;Level: PT;Classification code 10061630;Term: Adrenogenital syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: DectancylHospices Civils de LyonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
64EUCTR2015-000458-40-DE
(EUCTR)
20/10/201521/08/2015Open-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 studyOpen-label, long-term follow-up of safety and biochemical disease control of Infacort® in neonates, infants and children with congenital adrenal hyperplasia and adrenal insufficiency previously enrolled in the Infacort 003 study - Infacort004 Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. Current standard treatment in neonates is unsatisfactory, as unlicensed and crushed adult dosage formulations (Hydrocortisone tablets,10 mg) are used. Infacort® is a new paediatric and neonatal formulation of hydrocortisone that is provided in appropriate unit dosage (0.5mg, 1.0mg, 2.0mg and 5mg);Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
Other descriptive name: HYDROCORTISONE
Diurnal LimitedNULLNot Recruiting Female: yes
Male: yes
24 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany
65EUCTR2014-002265-30-DE
(EUCTR)
19/02/201523/12/2014A Phase 3 open-label study of Infacort® in neonates, infants and children less than 6 years of age with adrenal insufficiency.A Phase 3 open-label study of Infacort® in neonates, infants and children less than 6 years of age with adrenal insufficiency. Adrenal Insufficiency (AI) in children is most commonly due to Congenital Adrenal Hyperplasia (CAH) and results in cortisol deficiency with or without aldosterone deficiency and androgen excess. Current standard treatment in neonates is unsatisfactory, as unlicensed and crushed adult dosage formulations (Hydrocortisone tablets, 10 mg) are used. Infacort® is a new paediatric and neonatal formulation of hydrocortisone that is provided in appropriate unit dosage (0.5mg, 1.0mg, 2.0mg and 5mg).;Therapeutic area: Diseases [C] - Hormonal diseases [C19]Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Product Name: infacort
INN or Proposed INN: infacort
Other descriptive name: HYDROCORTISONE
Diurnal LimitedNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
66NCT02349503
(ClinicalTrials.gov)
February 201520/1/2015Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal HyperplasiaA Phase 1, Open-Label, Single-Dose, Sequential Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: NBI-77860Neurocrine BiosciencesNULLWithdrawn12 Years18 YearsFemale0Phase 1United States
67EUCTR2011-005822-23-SE
(EUCTR)
18/11/201420/09/2013A trial comparing continuous subcutaneous hydrocortisone infusion (CSHI) therapy with conventional oral glucocorticoid therapy in patients with Congenital Andrenal Hyperplasia (CAH)CONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA Congenital Adrenal Hyperplasia
MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Solu-Cortef
INN or Proposed INN: HYDROCORTISONE SODIUM SUCCINATE
Other descriptive name: HYDROCORTISONE SODIUM SUCCINATE
INN or Proposed INN: Prednisolone
INN or Proposed INN: Hydrocortisone
Haukeland University HospitalNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Norway;Sweden
68EUCTR2012-001104-37-GB
(EUCTR)
06/10/201424/07/2014pulses studyPulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia - the pulses study Addison's disease and Congenital Adrenal Hyperplasia
MedDRA version: 17.0;Level: LLT;Classification code 10011195;Term: Cortisol;System Organ Class: 100000004848
MedDRA version: 17.0;Classification code 10020518;Term: Hydrocortisone;System Organ Class: 100000004848;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: hydrocortisone sodium phosphate
Product Name: hydrocortisone sodium phosphate
INN or Proposed INN: hydrocortisone sodium phosphate
Trade Name: hydrocortisone
Product Name: hydrocortisone
INN or Proposed INN: hydrocortisone
University Hospitals Bristol NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
69NCT02096510
(ClinicalTrials.gov)
August 201428/11/2013Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal HyperplasiaUltradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal HyperplasiaAddison Disease;Adrenal Hyperplasia CongenitalDrug: Solu-Cortef;Drug: CortefHaukeland University HospitalNULLRecruiting18 Years65 YearsBoth10Phase 1/Phase 2Norway
70EUCTR2013-002395-40-BE
(EUCTR)
24/03/201419/11/2013Prospective intervention trial with adjuvant metformin in girls and boys with classic congenital adrenal hyperplasia.Prospective intervention trial with adjuvant metformin in girls and boys with classic CAH (METFOR CAH). - METFOR CAH congenital adrenal hyperplasia (CAH)
MedDRA version: 16.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Metformine Sandoz 850 mg filmomhulde tabletten
Product Name: Metformine
INN or Proposed INN: METFORMIN HYDROCHLORIDE
Other descriptive name: METFORMIN HYDROCHLORIDE
Ghent University HospitalNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Belgium
71NCT01859312
(ClinicalTrials.gov)
May 6, 201317/5/2013Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal HyperplasiaA Pilot Study Assessing the Use of Continuous Subcutaneous Hydrocortisone Infusion in the Treatment of Congenital Adrenal HyperplasiaAdrenal Insufficiency;Excess Androgen;Congenital Adrenal Hyperplasia (CAH)Drug: Hydrocortisone (Solucortef);Device: Insulin pump (Medtronic)National Institutes of Health Clinical Center (CC)Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Completed18 Years99 YearsAll8Phase 2United States
72NCT01771328
(ClinicalTrials.gov)
February 201310/1/2013Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal HyperplasiaContinuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal HyperplasiaAdrenal Hyperplasia, CongenitalDrug: Hydrocortisone;Drug: Cortisone acetateHaukeland University HospitalNULLRecruiting18 Years60 YearsBoth20Phase 2Norway
73NCT01735617
(ClinicalTrials.gov)
December 201220/11/2012Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAHA Phase 2 Pilot Study to Characterize and Examine the Pharmacokinetics and Disease Bio-marker Response of Chronocort® in Adults With Congenital Adrenal HyperplasiaEndocrine Disease;Adrenal Insufficiency;Congenital Adrenal HyperplasiaDrug: Hydrocortisone Modified Release CapsulesDiurnal LimitedNational Institutes of Health (NIH)Completed18 YearsN/AAll16Phase 2United States
74EUCTR2011-005822-23-NO
(EUCTR)
16/10/201225/02/2013A trial comparing continuous subcutaneous hydrocortisone therapy with conventional oral glucocorticoid therapy in congenital adrenal hyperplasiaCONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIA Congenital adrenal hyperplasia (CAH)
MedDRA version: 14.1;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: Solu-Cortef
Trade Name: Cortison
Trade Name: Prednisolone
Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Norway
75NCT02552251
(ClinicalTrials.gov)
August 201227/7/2015COrticosteroid in Congenital Adrenal HyperplasiaComparative Study of the Use of Glucocorticoids in the Treatment of Congenital Adrenal Hyperplasia in Its Classical FormCongenital Adrenal HyperplasiaBiological: Hormonal balance measurements;Biological: metabolic balance measurements;Biological: bone balance measurements;Behavioral: quality of life assessmentUniversity Hospital, CaenNULLRecruiting18 Years55 YearsFemale40Phase 2/Phase 3France
76NCT01495910
(ClinicalTrials.gov)
December 201123/11/2011A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase DeficiencyAn Open-Label, Multiple-Dose, Dose-Finding Study of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency21-hydroxylase DeficiencyDrug: Abiraterone acetateJohnson & Johnson Pharmaceutical Research & Development, L.L.C.NULLCompleted18 YearsN/AFemale6Phase 1United States
77NCT03051893
(ClinicalTrials.gov)
February 201111/1/2017A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort FormulationsA Two-part Open Label, Randomised, Single Dose, Crossover Study in Healthy Volunteers to: (Part A) Compare the Pharmacokinetics of up to 6 Chronocort® Formulations, and (Part B) Determine the Dose Proportionality of a Selected Chronocort® Formulation at Three Dose Levels With an Additional Comparison With the Selected Formulation Dosed on Two Occasions Over a 24 Hour PeriodAdrenal Insufficiency;Congenital Adrenal HyperplasiaDrug: ChronocortDiurnal LimitedSimbec ResearchCompleted18 Years60 YearsMale28Phase 1NULL
78NCT03019614
(ClinicalTrials.gov)
March 201011/1/2017An Open Label Study in Healthy Volunteers to Compare Chronocort® to HydrocortisoneAn Open Label, Randomised, Single Dose, 3-period Crossover Study in Healthy Volunteers to: a) Compare the Pharmacokinetics of Chronocort® Formulations Versus Immediate Release Hydrocortisone, and (b) Determine the Dose Proportionality of Chronocort® FormulationsCongenital Adrenal Hyperplasia;Adrenal InsufficiencyDrug: Hydrocortisone;Drug: ChronocortDiurnal LimitedSimbec ResearchCompleted18 Years60 YearsMale30Phase 1NULL
79NCT00621985
(ClinicalTrials.gov)
April 200811/2/2008Dexamethasone Treatment of Congenital Adrenal HyperplasiaDexamethasone Treatment of Congenital Adrenal HyperplasiaAdrenal Hyperplasia, CongenitalDrug: dexamethasone;Drug: HydrocortisoneBoston Children’s HospitalNULLCompleted2 Years9 YearsAll5Phase 2United States
80NCT00519818
(ClinicalTrials.gov)
August 200722/8/2007Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal HyperplasiaA Phase 2, Open Label, Crossover Pharmacokinetic and Pharmacodynamic Study to Compare Chronocort Versus Cortef in Patients With CAHCongenital Adrenal Hyperplasia;21-Hydroxylase Deficiency;Adrenogenital SyndromeDrug: Chronocort;Drug: CortefDiurnal LimitedNational Institutes of Health Clinical Center (CC)Completed16 Years60 YearsAll20Phase 1/Phase 2United States
81NCT00542841
(ClinicalTrials.gov)
August 200710/10/2007Examining Genetic Differences Among People With 21-Hydroxylase DeficiencyModifier Genes in 21-Hydroxylase Deficiency21-hydroxylase DeficiencyProcedure: Hydrocortisone withdrawalMaria I. NewOffice of Rare Diseases (ORD);National Center for Research Resources (NCRR)Completed18 Years50 YearsBoth99N/AUnited States;Brazil;France
82NCT00529841
(ClinicalTrials.gov)
January 200712/9/2007Research Study for Children With Salt Wasting Congenital Adrenal HyperplasiaA Novel Therapeutic Modality for Congenital Adrenal HyperplasiaAdrenal Hyperplasia, CongenitalDrug: Hydrocortisone sodium acetateBaylor College of MedicineNULLCompleted3 Years18 YearsBoth7N/AUnited States
83NCT00151710
(ClinicalTrials.gov)
May 20058/9/2005Effects of Pioglitazone in Congenital Adrenal HyperplasiaEffects of Pioglitazone in Glucocorticoid-Induced Insulin Resistance. Studies in Congenital Adrenal Hyperplasia.Congenital Adrenal HyperplasiaDrug: PioglitazoneRadboud UniversityNULLCompleted18 YearsN/ABothN/ANetherlands
84NCT00001521
(ClinicalTrials.gov)
June 8, 19953/11/1999Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal HyperplasiaAn Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal HyperplasiaCongenital Adrenal Hyperplasia (CAH)Drug: Flutamide;Drug: Letrozole;Drug: Hydrocortisone;Drug: FludrocortisoneEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NULLActive, not recruiting2 Years18 YearsAll62Phase 2United States
85EUCTR2021-004467-26-FR
(EUCTR)
09/12/2021An Open-label Extension Study to Evaluate the Long-term Safety andTolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over with Congenital Adrenal HyperplasiaA Phase 3 Open-label Extension Study to Evaluate the Long-term Safety andTolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia Congenital Adrenal Hyperplasia due to 21-hydroxylase deficiency;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Efmody 5 mg modified release hard capsules
Product Name: Chronocort 5mg
INN or Proposed INN: HYDROCORTISONE
Other descriptive name: HYDROCORTISONE MICRONIZED
Trade Name: Efmody 10 mg modified release hard capsules
Product Name: Chronocort 10mg
INN or Proposed INN: hydrocortisone
Other descriptive name: HYDROCORTISONE MICRONIZED
Diurnal LimitedNULLNAFemale: yes
Male: yes
181Phase 3United States;France;Japan
86EUCTR2020-004381-19-PL
(EUCTR)
10/05/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA 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.NULLNAFemale: yes
Male: yes
81Phase 3United States;France;Greece;Canada;Spain;Belgium;Poland;Germany;Italy;Sweden
87NCT00000102
(ClinicalTrials.gov)
3/11/1999Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic TargetsCongenital Adrenal HyperplasiaDrug: NifedipineNational Center for Research Resources (NCRR)NULLCompleted14 Years35 YearsBothPhase 1/Phase 2United States
88EUCTR2020-004381-19-BE
(EUCTR)
25/06/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA 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.NULLNAFemale: yes
Male: yes
81Phase 3France;United States;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden