Infacort ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
81先天性副腎皮質酵素欠損症3

81. 先天性副腎皮質酵素欠損症


臨床試験数 : 87 薬物数 : 87 - (DrugBank : 23) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 68
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02733367
(ClinicalTrials.gov)
March 4, 201616/3/2016Extension 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 LimitedNULLCompleted1 Month6 YearsAll18Phase 3Germany
2EUCTR2015-000458-40-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
3EUCTR2014-002265-30-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