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.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03548246 | September 2020 | 30 September 2019 | Androgen Reduction in Congenital Adrenal Hyperplasia | A 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 Deficiency | Congenital Adrenal Hyperplasia | Drug: Abiraterone acetate;Drug: Placebo;Drug: Hydrocortisone;Drug: Fludrocortisone | University of Texas Southwestern Medical Center | National Institutes of Health Clinical Center (CC);University of Michigan;Children's Hospital Los Angeles;Feinstein Institute for Medical Research | Not recruiting | 2 Years | 9 Years | All | 54 | Phase 2 | United States |
| 2 | NCT04045145 | September 2019 | 30 September 2019 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects With Congenital Adrenal Hyperplasia | A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Pediatric Subjects With Congenital Adrenal Hyperplasia | CAH - Congenital Adrenal Hyperplasia | Drug: NBI-74788 | Neurocrine Biosciences | Recruiting | 14 Years | 17 Years | All | 12 | Phase 2 | United States | |
| 3 | NCT03718234 | January 1, 2019 | 11 November 2019 | Subcutaneous Hydrocortisone Children With Congenital Adrenal Hyperplasia | Interval Bolus Delivery of Subcutaneous Hydrocortisone Via Infusion Pump in Children With Congenital Adrenal Hyperplasia | Congenital 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;Hydrocortisone | Drug: Subcutaneous hydrocortisone;Drug: Standard glucocorticoid therapy | University of Minnesota | Recruiting | 4 Years | 18 Years | All | 8 | Phase 1 | United States | |
| 4 | NCT03532022 | October 4, 2018 | 5 November 2018 | Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy | An 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 Hyperplasia | Congenital Adrenal Hyperplasia | Drug: Standard Care;Drug: Chronocort® | Diurnal Limited | National Institutes of Health (NIH) | Not recruiting | 16 Years | N/A | All | 132 | Phase 3 | United States |
| 5 | NCT03687242 | September 6, 2018 | 15 July 2019 | Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia | A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia | Congenital Adrenal Hyperplasia;CAH - Congenital Adrenal Hyperplasia;CAH - 21-Hydroxylase Deficiency | Drug: SPR001 | Spruce Biosciences | Not recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2017-004878-34-ES | 01/08/2018 | 20 August 2018 | A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia | A 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 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. | Authorised | Female: yes Male: yes | 24 | Phase 2 | Brazil;Spain;Israel | |||
| 7 | NCT03669549 | July 11, 2018 | 9 September 2019 | Nevanimibe HCl for the Treatment of Classic CAH | A Multicenter Dose-Titration Open-Label Study of Nevanimibe Hydrochloride for the Treatment of Classic Congenital Adrenal Hyperplasia | Congenital Adrenal Hyperplasia | Drug: Nevanimibe hydrochloride | Millendo Therapeutics US, Inc. | Recruiting | 18 Years | 80 Years | All | 24 | Phase 2 | Brazil;Czechia;France;Israel;Spain | |
| 8 | NCT03525886 | April 10, 2018 | 26 August 2019 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal Hyperplasia | A Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects With Congenital Adrenal Hyperplasia | CAH - Congenital Adrenal Hyperplasia | Drug: NBI-74788 | Neurocrine Biosciences | Recruiting | 18 Years | 50 Years | All | 30 | Phase 2 | United States | |
| 9 | NCT02574910 | August 1, 2017 | 4 February 2019 | Androgen Reduction in Congenital Adrenal Hyperplasia, Phase 1 | A 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 Deficiency | Congenital Adrenal Hyperplasia | Drug: Abiraterone acetate | University of Texas Southwestern Medical Center | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);University of Michigan;Children's Hospital Los Angeles | Recruiting | 2 Years | 9 Years | All | 36 | Phase 1 | United States |
| 10 | NCT03257462 | July 26, 2017 | 15 July 2019 | Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia | A Phase 2, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Efficacy of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia (CAH) | Congenital Adrenal Hyperplasia;CAH - Congenital Adrenal Hyperplasia | Drug: SPR001 | Spruce Biosciences | Not recruiting | 18 Years | N/A | All | 26 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03062280 | August 18, 2016 | 29 April 2019 | A Study of the Efficacy, Safety and Tolerability of Chronocort in Treating CAH | A Phase III Extension Study of Efficacy, Safety and Tolerability of Chronocort® in the Treatment of Congenital Adrenal Hyperplasia | Congenital Adrenal Hyperplasia | Drug: Hydrocortisone | Diurnal Limited | Not recruiting | 18 Years | N/A | All | 92 | Phase 3 | United States | |
| 12 | NCT03760835 | August 11, 2016 | 26 August 2019 | Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment | Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment | Congenital Adrenal Hyperplasia | Drug: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone);Drug: Dual release hydrocortisone (plenadren) | Federico II University | Recruiting | 18 Years | N/A | All | 150 | Phase 4 | Italy | |
| 13 | EUCTR2015-005448-32-GB | 20/07/2016 | 24 September 2018 | The 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 Ltd | Authorised | Female: yes Male: yes | 136 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | |||
| 14 | EUCTR2015-000711-40-DE | 23/05/2016 | 30 April 2019 | Chronocort®, 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 Ltd | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | |||
| 15 | NCT02804178 | May 18, 2016 | 11 June 2018 | A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia | A Phase 2, Multicenter Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia | Congenital Adrenal Hyperplasia | Drug: ATR-101 | Millendo Therapeutics, Inc. | Not recruiting | 18 Years | 80 Years | All | 15 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02733367 | March 4, 2016 | 25 February 2019 | Extension Study for Patients Entered Into Study Infacort 003 | Open-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 | Adrenal Insufficiency | Drug: Infacort® | Diurnal Limited | Not recruiting | 1 Month | 6 Years | All | 18 | Phase 3 | Germany | |
| 17 | NCT02716818 | February 22, 2016 | 17 September 2018 | Comparison of Chronocort® With Standard Glucocorticoid Therapy in Patients With Congenital Adrenal Hyperplasia | 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 | Drug: Chronocort®;Drug: standard glucocorticoid therapy | Diurnal Limited | Not recruiting | 18 Years | N/A | All | 122 | Phase 3 | United States | |
| 18 | EUCTR2015-000711-40-GB | 19/11/2015 | 28 February 2019 | Chronocort®, 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 Ltd | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Denmark;Netherlands;Germany;United Kingdom;Sweden | |||
| 19 | EUCTR2015-003996-32-FR | 03/11/2015 | 18 January 2016 | Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study | Multicentric 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: Dectancyl | Hospices Civils de Lyon | Authorised | Female: yes Male: yes | France | |||||
| 20 | EUCTR2015-000458-40-DE | 20/10/2015 | 28 February 2019 | Open-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 | Open-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 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 Limited | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Germany | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2014-002265-30-DE | 19/02/2015 | 3 July 2017 | A 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 Limited | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | ||||
| 22 | NCT02349503 | February 2015 | 29 June 2015 | Safety, Pharmacokinetics and Pharmacodynamics of NBI-77860 in Adolescent Females With Congenital Adrenal Hyperplasia | A 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 Hyperplasia | Congenital Adrenal Hyperplasia | Drug: NBI-77860 | Neurocrine Biosciences | Not recruiting | 12 Years | 18 Years | Female | 0 | Phase 1 | United States | |
| 23 | EUCTR2012-001104-37-GB | 06/10/2014 | 23 March 2015 | pulses study | Pulsed 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 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 Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 24 | NCT02096510 | August 2014 | 9 January 2017 | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia | Ultradian Subcutaneous Hydrocortisone Infusion in Addison Disease and Congenital Adrenal Hyperplasia | Addison Disease;Adrenal Hyperplasia Congenital | Drug: Solu-Cortef;Drug: Cortef | Haukeland University Hospital | Recruiting | 18 Years | 65 Years | Both | 10 | Phase 1/Phase 2 | Norway | |
| 25 | EUCTR2013-002395-40-BE | 24/03/2014 | 5 March 2018 | Prospective 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 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 Hospital | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Belgium | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT01859312 | May 6, 2013 | 16 December 2017 | Comparison of Cortisol Pump With Standard Treatment for Congenital Adrenal Hyperplasia | A Pilot Study Assessing the Use of Continuous Subcutaneous Hydrocortisone Infusion in the Treatment of Congenital Adrenal Hyperplasia | Adrenal 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 recruiting | 18 Years | 99 Years | All | 8 | Phase 2 | United States |
| 27 | NCT01771328 | February 2013 | 9 January 2017 | Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia | Continuous Subcutaneous Hydrocortisone Infusion in Congenital Adrenal Hyperplasia | Adrenal Hyperplasia, Congenital | Drug: Hydrocortisone;Drug: Cortisone acetate | Haukeland University Hospital | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 2 | Norway | |
| 28 | NCT01735617 | December 2012 | 16 December 2017 | Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH | A Phase 2 Pilot Study to Characterize and Examine the Pharmacokinetics and Disease Bio-marker Response of Chronocort® in Adults With Congenital Adrenal Hyperplasia | Endocrine Disease;Adrenal Insufficiency;Congenital Adrenal Hyperplasia | Drug: Hydrocortisone Modified Release Capsules | Diurnal Limited | National Institutes of Health (NIH) | Not recruiting | 18 Years | N/A | All | 16 | Phase 2 | United States |
| 29 | EUCTR2011-005822-23-NO | 16/10/2012 | 4 March 2013 | A trial comparing continuous subcutaneous hydrocortisone therapy with conventional oral glucocorticoid therapy in congenital adrenal hyperplasia | CONTINUOUS 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 Pharmaceutical Form: Powder and solvent for solution for infusion Trade Name: Cortison Pharmaceutical Form: Tablet Trade Name: Prednisolone Pharmaceutical Form: Tablet | Haukeland University Hospital | Authorised | Female: yes Male: yes | Norway | |||||
| 30 | NCT02552251 | August 2012 | 28 September 2015 | COrticosteroid in Congenital Adrenal Hyperplasia | Comparative Study of the Use of Glucocorticoids in the Treatment of Congenital Adrenal Hyperplasia in Its Classical Form | Congenital Adrenal Hyperplasia | Biological: Hormonal balance measurements;Biological: metabolic balance measurements;Biological: bone balance measurements;Behavioral: quality of life assessment | University Hospital, Caen | Recruiting | 18 Years | 55 Years | Female | 40 | Phase 2/Phase 3 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT01495910 | December 2011 | 19 February 2015 | A Study Examining Doses of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency | An Open-Label, Multiple-Dose, Dose-Finding Study of Abiraterone Acetate in Adult Women With 21-Hydroxylase Deficiency | 21-hydroxylase Deficiency | Drug: Abiraterone acetate | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Not recruiting | 18 Years | N/A | Female | 6 | Phase 1 | United States | |
| 32 | NCT03051893 | February 2011 | 16 December 2017 | A Two-part, Study to Compare the Pharmacokinetics and Dose Proportionality of up to 6 Chronocort Formulations | A 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 Period | Adrenal Insufficiency;Congenital Adrenal Hyperplasia | Drug: Chronocort | Diurnal Limited | Simbec Research | Not recruiting | 18 Years | 60 Years | Male | 28 | Phase 1 | |
| 33 | NCT03019614 | March 2010 | 16 December 2017 | An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone | An 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® Formulations | Congenital Adrenal Hyperplasia;Adrenal Insufficiency | Drug: Hydrocortisone;Drug: Chronocort | Diurnal Limited | Simbec Research | Not recruiting | 18 Years | 60 Years | Male | 30 | Phase 1 | |
| 34 | NCT00621985 | April 2008 | 19 October 2017 | Dexamethasone Treatment of Congenital Adrenal Hyperplasia | Dexamethasone Treatment of Congenital Adrenal Hyperplasia | Adrenal Hyperplasia, Congenital | Drug: dexamethasone;Drug: Hydrocortisone | Boston Children’s Hospital | Not recruiting | 2 Years | 9 Years | All | 5 | Phase 2 | United States | |
| 35 | NCT00519818 | August 2007 | 19 October 2017 | Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia | A Phase 2, Open Label, Crossover Pharmacokinetic and Pharmacodynamic Study to Compare Chronocort Versus Cortef in Patients With CAH | Congenital Adrenal Hyperplasia;21-Hydroxylase Deficiency;Adrenogenital Syndrome | Drug: Chronocort;Drug: Cortef | Diurnal Limited | National Institutes of Health Clinical Center (CC) | Not recruiting | 16 Years | 60 Years | All | 20 | Phase 1/Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT00542841 | August 2007 | 21 December 2015 | Examining Genetic Differences Among People With 21-Hydroxylase Deficiency | Modifier Genes in 21-Hydroxylase Deficiency | 21-hydroxylase Deficiency | Procedure: Hydrocortisone withdrawal | Maria I. New | Office of Rare Diseases (ORD);National Center for Research Resources (NCRR) | Not recruiting | 18 Years | 50 Years | Both | 99 | N/A | United States;Brazil;France |
| 37 | NCT00529841 | January 2007 | 21 September 2015 | Research Study for Children With Salt Wasting Congenital Adrenal Hyperplasia | A Novel Therapeutic Modality for Congenital Adrenal Hyperplasia | Adrenal Hyperplasia, Congenital | Drug: Hydrocortisone sodium acetate | Baylor College of Medicine | Not recruiting | 3 Years | 18 Years | Both | 7 | N/A | United States | |
| 38 | NCT00151710 | May 2005 | 19 February 2015 | Effects of Pioglitazone in Congenital Adrenal Hyperplasia | Effects of Pioglitazone in Glucocorticoid-Induced Insulin Resistance. Studies in Congenital Adrenal Hyperplasia. | Congenital Adrenal Hyperplasia | Drug: Pioglitazone | Radboud University | Not recruiting | 18 Years | N/A | Both | N/A | Netherlands | ||
| 39 | NCT00001521 | February 2, 1996 | 4 November 2019 | Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia | An Open, Randomized, Long-Term Clinical Trial of Flutamide, Testolactone, and Reduced Hydrocortisone Dose vs. Conventional Treatment of Children With Congenital Adrenal Hyperplasia | Congenital Adrenal Hyperplasia (CAH) | Drug: Flutamide;Drug: Letrozole;Drug: Hydrocortisone | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Not recruiting | 2 Years | 18 Years | All | 62 | Phase 2 | United States | |
| 40 | NCT00000102 | 19 February 2015 | Congenital Adrenal Hyperplasia: Calcium Channels as Therapeutic Targets | Congenital Adrenal Hyperplasia | Drug: Nifedipine | National Center for Research Resources (NCRR) | Not recruiting | 14 Years | 35 Years | Both | Phase 1/Phase 2 | United States |