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 81. 先天性副腎皮質酵素欠損症 [臨床試験数:40,薬物数:58(DrugBank:21),標的遺伝子数:11,標的パスウェイ数:63] 

Searched query = "Congenital adrenal hyperplasia", "Congenital adrenal enzyme deficiency", "Congenial adrenal cortex enzyme deficiency", "Congenital Lipoid Adrenal Hyperplasia", "3β-Hydroxysteroid Dehydrogenase Deficiency", "21-Hydroxylase deficiency", "11β-Hydroxylase deficiency", "17α-Hydroxylase deficiency", "Aldosterone synthase deficiency", "P450 oxidoreductase deficiency"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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Target_
size
PhaseCountries
1NCT03548246September 202030 September 2019Androgen 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 recruiting2 Years9 YearsAll54Phase 2United States
2NCT04045145September 201930 September 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 BiosciencesRecruiting14 Years17 YearsAll12Phase 2United States
3NCT03718234January 1, 201911 November 2019Subcutaneous 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 MinnesotaRecruiting4 Years18 YearsAll8Phase 1United States
4NCT03532022October 4, 20185 November 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: Standard Care;Drug: Chronocort®Diurnal LimitedNational Institutes of Health (NIH)Not recruiting16 YearsN/AAll132Phase 3United States
5NCT03687242September 6, 201815 July 2019Study 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 BiosciencesNot recruiting18 YearsN/AAll24Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-004878-34-ES01/08/201820 August 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 HyperplasiaClassic 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
Pharmaceutical Form: Tablet
INN or Proposed INN: Nevanimibe hydrochloride
CAS Number: 133825-81-7
Current Sponsor code: ATR-101
Other descriptive name: CI-984, 17AA70, PD 132301-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 1000-2000
Millendo Therapeutics, Inc.AuthorisedFemale: yes
Male: yes
24Phase 2Brazil;Spain;Israel
7NCT03669549July 11, 20189 September 2019Nevanimibe 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.Recruiting18 Years80 YearsAll24Phase 2Brazil;Czechia;France;Israel;Spain
8NCT03525886April 10, 201826 August 2019Safety, 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 BiosciencesRecruiting18 Years50 YearsAll30Phase 2United States
9NCT02574910August 1, 20174 February 2019Androgen 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 AngelesRecruiting2 Years9 YearsAll36Phase 1United States
10NCT03257462July 26, 201715 July 2019Study 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 BiosciencesNot recruiting18 YearsN/AAll26Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03062280August 18, 201629 April 2019A 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 LimitedNot recruiting18 YearsN/AAll92Phase 3United States
12NCT03760835August 11, 201626 August 2019Congenital 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 UniversityRecruiting18 YearsN/AAll150Phase 4Italy
13EUCTR2015-005448-32-GB20/07/201624 September 2018The 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
Pharmaceutical Form: Capsule
INN or Proposed INN: HYDROCORTISONE
CAS Number: 50-23-7
Other descriptive name: Cortisol
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-20
Diurnal LtdAuthorisedFemale: yes
Male: yes
136Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
14EUCTR2015-000711-40-DE23/05/201630 April 2019Chronocort®, 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
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: HYDROCORTISONE
CAS Number: 50-23-7
Other descriptive name: Cortisol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Hydrocortisone 10mg Tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydrocortisone
CAS Number: 50-23-7
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: Dexamethasone 0.5mg Tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Product Name: Prednisolone 5mg Tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Product Name: Chronocort® 10 mg
Product Code: DIURF-006
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: HYDROCORTISONE
CAS Number: 50-23-7
Other descriptive name: Cortisol
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: Chronocort® 20 mg
Diurnal LtdNot Recruiting Female: yes
Male: yes
120Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
15NCT02804178May 18, 201611 June 2018A 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.Not recruiting18 Years80 YearsAll15Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
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agemin
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PhaseCountries
16NCT02733367March 4, 201625 February 2019Extension 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 LimitedNot recruiting1 Month6 YearsAll18Phase 3Germany
17NCT02716818February 22, 201617 September 2018Comparison 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 LimitedNot recruiting18 YearsN/AAll122Phase 3United States
18EUCTR2015-000711-40-GB19/11/201528 February 2019Chronocort®, 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
Pharmaceutical Form: Capsule
INN or Proposed INN: HYDROCORTISONE
CAS Number: 50-23-7
Other descriptive name: Cortisol
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 5-20
Trade Name: Hydrocortisone 20mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydrocortisone
CAS Number: 50-23-7
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Trade Name: Dexamethasone 2mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: DEXAMETHASONE
CAS Number: 50-02-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Trade Name: Prednisolone 1mg Tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Prednisolone
CAS Number: 50-24-8
Other descriptive name: PREDNISOLONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Diurnal LtdNot Recruiting Female: yes
Male: yes
120Phase 3France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden
19EUCTR2015-003996-32-FR03/11/201518 January 2016Multicentric 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 DEXPatient 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 LyonAuthorisedFemale: yes
Male: yes
France
20EUCTR2015-000458-40-DE20/10/201528 February 2019Open-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 - Infacort004Adrenal 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
Pharmaceutical Form: Granules
CAS Number: 50-23-7
Current Sponsor code: infacort
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Product Name: infacort
Pharmaceutical Form: Granules
CAS Number: 50-23-7
Current Sponsor code: infacort
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: infacort
Pharmaceutical Form: Granules
CAS Number: 50-23-7
Current Sponsor code: infacort
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Product Name: infacort
Pharmaceutical Form: Granules
CAS Number: 50-23-7
Current Sponsor code: infacort
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Diurnal LimitedNot Recruiting Female: yes
Male: yes
24Phase 3Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2014-002265-30-DE19/02/20153 July 2017A 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
Pharmaceutical Form: Granules
INN or Proposed INN: infacort
CAS Number: 50-23-7
Current Sponsor code: infacort
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5 -
Product Name: infacort
Pharmaceutical Form: Granules
INN or Proposed INN: infacort
CAS Number: 50-23-7
Current Sponsor code: infacort
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: infacort
Pharmaceutical Form: Granules
INN or Proposed INN: infacort
CAS Number: 50-23-7
Current Sponsor code: infacort
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Product Name: infacort
Pharmaceutical Form: Granules
INN or Proposed INN: infacort
CAS Number: 50-23-7
Current Sponsor code: infacort
Other descriptive name: HYDROCORTISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Diurnal LimitedNot RecruitingFemale: yes
Male: yes
Phase 3Germany
22NCT02349503February 201529 June 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 BiosciencesNot recruiting12 Years18 YearsFemale0Phase 1United States
23EUCTR2012-001104-37-GB06/10/201423 March 2015pulses studyPulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia - the pulses studyAddison'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 Level: LLT 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
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: hydrocortisone sodium phosphate
CAS Number: 6000 74 4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: Subcutaneous use
Trade Name: hydrocortisone
Product Name: hydrocortisone
Pharmaceutical Form: Capsule
INN or Proposed INN: hydrocortisone
CAS Number: 50-23-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
University Hospitals Bristol NHS Foundation TrustAuthorisedFemale: yes
Male: yes
United Kingdom
24NCT02096510August 20149 January 2017Ultradian 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 HospitalRecruiting18 Years65 YearsBoth10Phase 1/Phase 2Norway
25EUCTR2013-002395-40-BE24/03/20145 March 2018Prospective 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 CAHcongenital 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: METFORMIN HYDROCHLORIDE
Other descriptive name: METFORMIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 850-
Ghent University HospitalNot RecruitingFemale: yes
Male: yes
90Phase 3Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
Inclusion_
agemin
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agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT01859312May 6, 201316 December 2017Comparison 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)Not recruiting18 Years99 YearsAll8Phase 2United States
27NCT01771328February 20139 January 2017Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal HyperplasiaContinuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal HyperplasiaAdrenal Hyperplasia, CongenitalDrug: Hydrocortisone;Drug: Cortisone acetateHaukeland University HospitalRecruiting18 Years60 YearsBoth20Phase 2Norway
28NCT01735617December 201216 December 2017Pilot 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)Not recruiting18 YearsN/AAll16Phase 2United States
29EUCTR2011-005822-23-NO16/10/20124 March 2013A trial comparing continuous subcutaneous hydrocortisone therapy with conventional oral glucocorticoid therapy in congenital adrenal hyperplasiaCONTINUOUS SUBCUTANEOUS HYDROCORTISONE INFUSION IN CONGENITAL ADRENAL HYPERPLASIACongenital 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
Pharmaceutical Form: Powder and solvent for solution for infusion
Trade Name: Cortison
Pharmaceutical Form: Tablet
Trade Name: Prednisolone
Pharmaceutical Form: Tablet
Haukeland University HospitalAuthorisedFemale: yes
Male: yes
Norway
30NCT02552251August 201228 September 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, CaenRecruiting18 Years55 YearsFemale40Phase 2/Phase 3France
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
31NCT01495910December 201119 February 2015A 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.Not recruiting18 YearsN/AFemale6Phase 1United States
32NCT03051893February 201116 December 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 ResearchNot recruiting18 Years60 YearsMale28Phase 1
33NCT03019614March 201016 December 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 ResearchNot recruiting18 Years60 YearsMale30Phase 1
34NCT00621985April 200819 October 2017Dexamethasone Treatment of Congenital Adrenal HyperplasiaDexamethasone Treatment of Congenital Adrenal HyperplasiaAdrenal Hyperplasia, CongenitalDrug: dexamethasone;Drug: HydrocortisoneBoston Children’s HospitalNot recruiting2 Years9 YearsAll5Phase 2United States
35NCT00519818August 200719 October 2017Comparison 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)Not recruiting16 Years60 YearsAll20Phase 1/Phase 2United States
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36NCT00542841August 200721 December 2015Examining 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)Not recruiting18 Years50 YearsBoth99N/AUnited States;Brazil;France
37NCT00529841January 200721 September 2015Research Study for Children With Salt Wasting Congenital Adrenal HyperplasiaA Novel Therapeutic Modality for Congenital Adrenal HyperplasiaAdrenal Hyperplasia, CongenitalDrug: Hydrocortisone sodium acetateBaylor College of MedicineNot recruiting3 Years18 YearsBoth7N/AUnited States
38NCT00151710May 200519 February 2015Effects of Pioglitazone in Congenital Adrenal HyperplasiaEffects of Pioglitazone in Glucocorticoid-Induced Insulin Resistance. Studies in Congenital Adrenal Hyperplasia.Congenital Adrenal HyperplasiaDrug: PioglitazoneRadboud UniversityNot recruiting18 YearsN/ABothN/ANetherlands
39NCT00001521February 2, 19964 November 2019Three 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: HydrocortisoneEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Not recruiting2 Years18 YearsAll62Phase 2United States
40NCT0000010219 February 2015Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic TargetsCongenital Adrenal HyperplasiaDrug: NifedipineNational Center for Research Resources (NCRR)Not recruiting14 Years35 YearsBothPhase 1/Phase 2United States

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