Odevixibat for Biliary Atresia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA
Biliary Atresia
Odevixibat - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: From Baseline to Weeks 26, 52, 78 and 104

Week 104
Safety and Tolerability
Time to onset of any sentinel events
Week 26
Change in height
Change in mid-arm circumference
Change in pediatric end-stage liver disease (PELD) score
Change in weight
Week 26
Change in serum bile acids
Week 104
Change in Fibrosis-4 (Fib-4) score
Change in aspartate aminotransferase (AST) to platelet ratio index (APRI) score
Proportion of patients who are alive and have not undergone liver transplant

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Odevixibat (A4250)
1 of 1
Experimental Treatment

180 Total Participants · 1 Treatment Group

Primary Treatment: Odevixibat · No Placebo Group · Phase 3

Odevixibat (A4250)
Drug
Experimental Group · 1 Intervention: Odevixibat · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to weeks 26, 52, 78 and 104
Closest Location: UPMC Children's Hospital of Pittsburgh · Pittsburgh, PA
Photo of Pittsburgh 1Photo of Pittsburgh 2Photo of Pittsburgh 3
2021First Recorded Clinical Trial
6 TrialsResearching Biliary Atresia
16 CompletedClinical Trials

Who is running the clinical trial?

AlbireoLead Sponsor
15 Previous Clinical Trials
950 Total Patients Enrolled
1 Trials studying Biliary Atresia
200 Patients Enrolled for Biliary Atresia

Eligibility Criteria

Age Any Age · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You completed the 104-week Treatment Period of Study A4250-011.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.