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Clinical trials for 21-hydroxylase deficiency

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    12 result(s) found for: 21-hydroxylase deficiency. Displaying page 1 of 1.
    EudraCT Number: 2018-004802-24 Sponsor Protocol Number: NL68556.091.18 Start Date*: 2019-05-20
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: Optimizing timing of glucocorticoid treatment in children with congenital adrenal hyperplasia
    Medical condition: Congenital adrenal hyperplasia (CAH) is a disorder of adrenal steroid synthesis leading to cortisol deficiency and an increase in androgen production.Treatment in children consists of hydrocortis...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-000711-40 Sponsor Protocol Number: DIUR-005 Start Date*: 2015-11-19
    Sponsor Name:Diurnal Ltd
    Full Title: A Phase III study of efficacy, safety and tolerability of Chronocort® compared with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia.
    Medical condition: 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, ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) SE (Completed) NL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-002395-40 Sponsor Protocol Number: AGO/2013/007 Start Date*: 2014-03-24
    Sponsor Name:Ghent University Hospital
    Full Title: Prospective intervention trial with adjuvant metformin in girls and boys with classic CAH (METFOR CAH).
    Medical condition: congenital adrenal hyperplasia (CAH)
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-003668-29 Sponsor Protocol Number: DIUR-014 Start Date*: 2022-02-04
    Sponsor Name:Diurnal Limited
    Full Title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study of Chronocort Compared with Immediate-Release Hydrocortisone Replacement Therapy in Participants Aged 16 Years and Over with Congenital ...
    Medical condition: Congenital Adrenal Hyperplasia due to 21-hydroxylase deficiency
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2021-004467-26 Sponsor Protocol Number: DIUR015 Start Date*: 2022-02-08
    Sponsor Name:Neurocrine UK Limited
    Full Title: A Phase 3 Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over with Congenital Adrenal Hyperplasia
    Medical condition: Congenital Adrenal Hyperplasia due to 21-hydroxylase deficiency
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004764-22 Sponsor Protocol Number: SPR001-203 Start Date*: 2020-10-15
    Sponsor Name:Spruce Biosciences, Inc.
    Full Title: 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
    Medical condition: Classic Congenital Adrenal Hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) SE (Trial now transitioned) DE (Ongoing) DK (Trial now transitioned) GB (GB - no longer in EU/EEA) PL (Trial now transitioned) IT (Trial now transitioned) LT (Trial now transitioned) LV (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-003062-18 Sponsor Protocol Number: 4071 Start Date*: 2008-06-05
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Trust
    Full Title: Immunotherapeutic Rescue of steroidogenic function in autoimmune Addison’s Disease (RAD): Pilot study
    Medical condition: Autoimmune Addison's disease (adrenocortical failure)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001343 Adrenal cortical hypofunctions HLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005448-32 Sponsor Protocol Number: DIUR-006 Start Date*: 2016-07-20
    Sponsor Name:Diurnal Ltd
    Full Title: A Phase III extension study of efficacy, safety and tolerability of Chronocort® in the treatment of congenital adrenal hyperplasia (CAH)
    Medical condition: 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, ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) DE (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004873-17 Sponsor Protocol Number: NBI-74788-CAH3003 Start Date*: 2020-10-15
    Sponsor Name:Neurocrine Biosciences, Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-...
    Medical condition: Classic Congenital Adrenal Hyperplasia (CAH)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) CZ (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) BG (Trial now transitioned) PL (Trial now transitioned) GR (Trial now transitioned) AT (Trial now transitioned) NL (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-001682-33 Sponsor Protocol Number: 6176/RADS2 Start Date*: 2012-09-06
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: Combined Immunotherapy and Trophic Adrenocortical Stimulation in New Onset Autoimmune Addison’s Disease
    Medical condition: Autoimmune Addison's disease: autoimmune primary adrenal insufficiency
    Disease: Version SOC Term Classification Code Term Level
    16.1 10014698 - Endocrine disorders 10052381 Primary adrenal insufficiency PT
    16.1 10014698 - Endocrine disorders 10001335 Adrenal cortex insufficiency LLT
    16.1 10014698 - Endocrine disorders 10001342 Adrenal cortical hypofunction LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-004878-34 Sponsor Protocol Number: ATR-101-202 Start Date*: 2018-09-18
    Sponsor Name:Millendo Therapeutics, Inc.
    Full Title: A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia
    Medical condition: Classic Congenital Adrenal Hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004765-40 Sponsor Protocol Number: SPR001-204 Start Date*: 2020-11-17
    Sponsor Name:Spruce Biosciences, Inc.
    Full Title: 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 Co...
    Medical condition: Classic Congenital Adrenal Hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010323 Congenital adrenal hyperplasia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned) SE (Trial now transitioned) PL (Trial now transitioned) LT (Trial now transitioned) LV (Trial now transitioned) IT (Trial now transitioned) EE (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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