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Ion Exchange Resin
Odevixibat for Biliary Atresia (BOLD-EXT Trial)
Phase 3
Waitlist Available
Research Sponsored by Albireo
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
BOLD-EXT Trial Summary
This trial will evaluate the long-term efficacy and safety of odevixibat in children with biliary atresia.
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.Check my eligibility
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.See study design
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.
BOLD-EXT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to weeks 26, 52, 78 and 104
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to weeks 26, 52, 78 and 104
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients who are alive and have not undergone liver transplant
Secondary outcome measures
Change in Fibrosis-4 (Fib-4) score
Change in aspartate aminotransferase (AST) to platelet ratio index (APRI) score
Change in height
+5 moreSide effects data
From 2022 Phase 3 trial • 52 Patients • NCT0467476129%
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%
Weight decreased
6%
Asthenia
6%
Conjunctivitis
6%
Vomiting
6%
Gastroenteritis
6%
Nasopharyngitis
3%
Coagulopathy
3%
Otitis media
3%
Blood triglycerides increased
3%
Gamma-glutamyltransferase increased
3%
Hypophagia
3%
Vitamin A decreased
3%
Headache
3%
Anaemia macrocytic
3%
Tonsillitis
3%
Contusion
3%
Pain in extremity
3%
Oropharyngeal pain
3%
Pharyngeal inflammation
3%
Pharyngitis
3%
Viral infection
3%
Urticaria
3%
Frequent bowel movements
3%
Hypersensitivity
3%
Rhinitis allergic
3%
Skin lesion
3%
Lymphadenopathy
3%
Hepatic enzyme increased
3%
Vitamin E decreased
3%
Vitamin D deficiency
3%
Abdominal pain upper
3%
Faeces soft
3%
Asthma
3%
Faeces discoloured
3%
Constipation
3%
Haematemesis
3%
Pneumonia
3%
Rhinovirus infection
3%
Nausea
3%
Alanine aminotransferase increased
3%
Ligament sprain
3%
Platelet count decreased
3%
Rhinorrhoea
3%
Jaundice
3%
Aphthous ulcer
3%
International normalised ratio increased
3%
Cataract cortical
100%
80%
60%
40%
20%
0%
Study treatment Arm
Odevixibat (A4250)
Placebo
BOLD-EXT 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?
AlbireoLead Sponsor
16 Previous Clinical Trials
991 Total Patients Enrolled
1 Trials studying Biliary Atresia
245 Patients Enrolled for Biliary Atresia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are in need of a liver transplant or are scheduled to receive one soon according to the investigator's judgement.You have a known allergy to any ingredients in odevixibat.
Research Study Groups:
This trial has the following groups:- Group 1: Odevixibat (A4250)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study recruiting new participants at this time?
"According to the information available on clinicaltrials.gov, this study is no longer recruiting patients. This study was first posted on July 5th, 2022 and was last edited on August 5th, 2022. There are 12 other studies that are currently recruiting patients."
Answered by AI
When might Odevixibat be available for general medical use?
"Odevixibat's safety is estimated to be a 3. This is due to the fact that Odevixibat is in Phase 3 trials, suggesting that while there is efficacy data, there is also extensive safety data."
Answered by AI
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