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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02733367 (ClinicalTrials.gov) | March 4, 2016 | 16/3/2016 | 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 | NULL | Completed | 1 Month | 6 Years | All | 18 | Phase 3 | Germany |
| 2 | EUCTR2015-000458-40-DE (EUCTR) | 20/10/2015 | 21/08/2015 | 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 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 Limited | NULL | Not 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): no | Germany | ||
| 3 | EUCTR2014-002265-30-DE (EUCTR) | 19/02/2015 | 23/12/2014 | 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 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany |