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

  
34 trials found
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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
4NCT05063994
(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
5NCT04536662
(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
6EUCTR2018-004802-24-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
7NCT03718234
(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
8EUCTR2015-005448-32-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
9EUCTR2015-005448-32-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
10EUCTR2015-005448-32-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
11EUCTR2015-000711-40-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
12NCT03062280
(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
13NCT03760835
(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
14EUCTR2015-005448-32-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
15EUCTR2015-000711-40-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
16EUCTR2015-000711-40-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
17EUCTR2015-000711-40-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
18EUCTR2015-000711-40-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
19EUCTR2015-000458-40-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
20EUCTR2014-002265-30-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
21EUCTR2011-005822-23-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
22EUCTR2012-001104-37-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
23NCT02096510
(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
24NCT01859312
(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
25NCT01771328
(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
26NCT01735617
(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
27EUCTR2011-005822-23-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
28NCT03019614
(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
29NCT00621985
(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
30NCT00542841
(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
31NCT00519818
(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
32NCT00529841
(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
33NCT00001521
(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
34EUCTR2021-004467-26-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