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Ion Exchange Resin

Odevixibat for Biliary Atresia (BOLD-EXT Trial)

Phase 3
Waitlist Available
Research Sponsored by Albireo, an Ipsen Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to weeks 26, 52, 78 and 104
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a medication called odevixibat in children with a liver condition called Biliary Atresia. The medication aims to lower bile acids in the liver and intestines to help protect the liver and improve symptoms. Children who completed a previous related study can join this study to see if the medication is safe and effective over time.

Who is the study for?
This trial is for children with Biliary Atresia who completed a previous 104-week study of Odevixibat. They must have consent from a caregiver and cannot join if they're allergic to Odevixibat, need an imminent liver transplant, were non-compliant in the prior study, or have conditions that may risk their safety or study participation.
What is being tested?
The trial tests the long-term effects and safety of Odevixibat on children with Biliary Atresia. It's an extension of a prior study where participants continue to receive this medication under open-label conditions, meaning both researchers and participants know what treatment is being given.
What are the potential side effects?
While specific side effects are not listed here, generally speaking, medications like Odevixibat could potentially cause digestive issues, allergic reactions or impact liver function. The exact side effects will be monitored closely throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to weeks 26, 52, 78 and 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to weeks 26, 52, 78 and 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Fibrosis-4 (Fib-4) score
Change in aspartate aminotransferase (AST) to platelet ratio index (APRI) score
Change in mid-arm circumference
+1 more

Side effects data

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Odevixibat (A4250)Experimental Treatment1 Intervention
Capsules for oral administration 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?

Albireo, an Ipsen CompanyLead Sponsor
4 Previous Clinical Trials
464 Total Patients Enrolled
1 Trials studying Biliary Atresia
254 Patients Enrolled for Biliary Atresia
AlbireoLead Sponsor
16 Previous Clinical Trials
1,020 Total Patients Enrolled
1 Trials studying Biliary Atresia
254 Patients Enrolled for Biliary Atresia

Media Library

Odevixibat (Ion Exchange Resin) Clinical Trial Eligibility Overview. Trial Name: NCT05426733 — Phase 3
Biliary Atresia Research Study Groups: Odevixibat (A4250)
Biliary Atresia Clinical Trial 2023: Odevixibat Highlights & Side Effects. Trial Name: NCT05426733 — Phase 3
Odevixibat (Ion Exchange Resin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05426733 — Phase 3
~107 spots leftby Jul 2028
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