Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Lead Sponsor:
Albireo, an Ipsen Company
Conditions:
Biliary Atresia
Eligibility:
All Genders
Up to 111 years
Phase:
PHASE3
Brief Summary
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatop...
Detailed Description
Up to 70 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.
Eligibility Criteria
Inclusion
- A male or female patient with a clinical diagnosis of BA
- Age at Kasai HPE ≤90 days
- Eligible to start study treatment within 3 weeks post-Kasai HPE
- Key
Exclusion
- Patients with intractable ascites
- Ileal resection surgery
- ALT ≥10× upper limit of normal (ULN) at screening
- Patients reliant only on total parenteral nutrition, or not able to take study medication orally, at randomization
- Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
- Choledochal cystic disease
- INR \>1.6 (the patient may be treated with Vitamin K intravenously; sample may be redrawn and if INR is ≤1.6 at resampling the patient may be randomized)
- Any other conditions or abnormalities, including congenital abnormalities, major cardiac surgery, hepatic, biliary, or GI disease which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the patient, the integrity of study results, or patient compliance with study requirements
- Weight \<3.5kg at randomization
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2026
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04336722
Start Date
July 8 2020
End Date
June 26 2026
Last Update
December 30 2025
Active Locations (66)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Stanford Children's Health
Palo Alto, California, United States, 94304
3
Rady Children's Hospital
San Diego, California, United States, 92123
4
UCSF Benioff Children's Hospital San Francisco
San Francisco, California, United States, 94158