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Ion Channel Modulator

Odevixibat for Biliary Atresia

Phase 3
Recruiting
Research Sponsored by Albireo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patient with a clinical diagnosis of BA
Age at Kasai HPE ≤90 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to weeks 13, 26, 52 and 104
Awards & highlights

Study Summary

This trial will compare the effectiveness and safety of a new drug, odevixibat, to placebo in children with biliary atresia who have had a Kasai hepatoportoenterostomy.

Who is the study for?
This trial is for children with Biliary Atresia who've had a Kasai procedure before they were 90 days old. They should be able to start treatment within 3 weeks post-surgery and weigh more than 3.5kg. Children with severe liver issues, relying solely on IV nutrition, or having certain other conditions are not eligible.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Odevixibat versus a placebo in kids after Kasai surgery for Biliary Atresia. It's a Phase 3 trial where participants are randomly assigned to either the drug or placebo without knowing which one they receive.See study design
What are the potential side effects?
While specific side effects aren't listed here, Odevixibat could potentially cause digestive issues, reactions at the site of administration, changes in liver enzymes, and possibly affect growth due to its role in bile acid processing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with biliary atresia.
Select...
I had the Kasai procedure done before I was 3 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to weeks 13, 26, 52 and 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to weeks 13, 26, 52 and 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from randomization to first occurrence of liver transplant, or death
Secondary outcome measures
Percentage of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Percentage of participants with clinically significant changes in Abdominal Ultrasound findings
Percentage of participants with clinically significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
+6 more

Side effects data

From 2022 Phase 3 trial • 52 Patients • NCT04674761
29%
Diarrhoea
23%
Pyrexia
14%
COVID-19
11%
Abdominal pain
9%
Respiratory tract infection
9%
Cough
9%
Upper respiratory tract infection
9%
Bronchitis
9%
Haematoma
6%
Conjunctivitis
6%
Gastroenteritis
6%
Weight decreased
6%
Asthenia
6%
Vomiting
6%
Nasopharyngitis
3%
Gamma-glutamyltransferase increased
3%
Vitamin A decreased
3%
Vitamin E decreased
3%
Otitis media
3%
Tonsillitis
3%
Contusion
3%
Pharyngeal inflammation
3%
Anaemia macrocytic
3%
Headache
3%
Blood triglycerides increased
3%
Viral infection
3%
Urticaria
3%
Aphthous ulcer
3%
Frequent bowel movements
3%
Hypersensitivity
3%
Lymphadenopathy
3%
Pharyngitis
3%
Abdominal pain upper
3%
Asthma
3%
Faeces discoloured
3%
Vitamin D deficiency
3%
Hypophagia
3%
Hepatic enzyme increased
3%
Rhinorrhoea
3%
Pain in extremity
3%
Constipation
3%
Haematemesis
3%
Rhinovirus infection
3%
Alanine aminotransferase increased
3%
Ligament sprain
3%
Platelet count decreased
3%
International normalised ratio increased
3%
Cataract cortical
3%
Jaundice
3%
Coagulopathy
3%
Pneumonia
3%
Oropharyngeal pain
3%
Skin lesion
3%
Nausea
3%
Rhinitis allergic
3%
Faeces soft
100%
80%
60%
40%
20%
0%
Study treatment Arm
Odevixibat (A4250)
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Odevixibat (A4250)Experimental Treatment1 Intervention
Capsules for oral administration once daily for 104 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Capsules for oral administration (to match active) once daily for 104 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Odevixibat
2021
Completed Phase 3
~60

Find a Location

Who is running the clinical trial?

AlbireoLead Sponsor
16 Previous Clinical Trials
926 Total Patients Enrolled
1 Trials studying Biliary Atresia
180 Patients Enrolled for Biliary Atresia
Ipsen Medical DirectorStudy DirectorIpsen
258 Previous Clinical Trials
55,049 Total Patients Enrolled

Media Library

Odevixibat (Ion Channel Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT04336722 — Phase 3
Biliary Atresia Research Study Groups: Odevixibat (A4250), Placebo
Biliary Atresia Clinical Trial 2023: Odevixibat Highlights & Side Effects. Trial Name: NCT04336722 — Phase 3
Odevixibat (Ion Channel Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04336722 — Phase 3
~86 spots leftby Jun 2026
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