This Study Will Investigate the Efficacy and Safety of Odevixibat in Children with Biliary Atresia Who Have Undergone a Kasai HPE
Phase 1
- Conditions
- Biliary AtresiaMedDRA version: 20.0Level: LLTClassification code 10004653Term: Biliary atresiaSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2019-003807-37-FR
- Lead Sponsor
- Albireo AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
1. A male or female patient with a clinical diagnosis of BA
2. Age at Kasai HPE =90 days
3. Eligible to start study treatment within 3 weeks post-Kasai HPE
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Patients with intractable ascites
2. Ileal resection surgery
3. ALT =10× upper limit of normal (ULN) at screening
4. Patient on total parenteral nutrition at randomization
5. Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
6. Choledochal cystic disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method