A Phase 3 interventional study of Odevixibat and Placebo in Biliary Atresia, sponsored by Albireo, an Ipsen Company. Completed at 72 sites in 19 countries. Open to participants aged Up to 111 Days. Per ClinicalTrials.gov, last updated 2026-07-02.
Sponsored by Albireo, an Ipsen Company · Phase 3, Interventional, and Treatment
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 hepatoportoenterostomy.
Up to 70 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.
75 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.
This study's enrollment of 254 is above the median of 43 across 42 interventional studies indexed under Biliary Atresia.
Browse Biliary Atresia studies →Albireo, an Ipsen Company is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Key Exclusion Criteria:
Capsules for oral administration once daily for 104 weeks.
Drug: Odevixibat
Capsules for oral administration (to match active) once daily for 104 weeks.
Drug: Placebo
Odevixibat is a small molecule and selective inhibitor of IBAT.
Placebo identical in appearance to experimental drug (odevixibat).
Time from randomization to first occurrence of liver transplant, or death
Time frame: From baseline to Week 104
Proportion of patients with liver transplant
Proportion of patients who are alive and have not undergone a liver transplant
Time frame: From baseline to Week 104
Time to onset of any sentinel events
Time to onset of any sentinel events
Time frame: From baseline to Week 104
Total bilirubin levels
Total bilirubin level after 13, 26, 52, and 104 weeks of study treatment
Time frame: From baseline to Weeks 13, 26, 52 and 104
Serum bile acid levels
Serum bile acid level after 13, 26, 52, and 104 weeks of study treatment
Time frame: From baseline to Weeks 13, 26, 52 and 104
Time to pediatric end-stage liver disease (PELD) score >15
Time to pediatric end-stage liver disease (PELD) score \>15
Time frame: From baseline to Week 104
Percentage of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Time frame: From baseline to Week 104
Percentage of participants with clinically significant changes in Physical Examination
Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator.
Time frame: From baseline to Week 104
Percentage of participants with clinically significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator.
Time frame: From baseline to Week 104
Percentage of participants with clinically significant changes in Abdominal Ultrasound findings
Percentage of participants with clinically significant change in Abdominal Ultrasound findings will be reported. The clinical significance will be decided by the investigator.
Time frame: From baseline to Week 26 and Week 104
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Albireo, an Ipsen Company