BridgeMD
An extension study to evaluate the long-term efficacy and safety of odevixibat (A4250) in children with biliary atresia (BOLD-EXT)
EU CTIS ID: 2022-501090-39-00
What this study is testing
To demonstrate a sustained effect of odevixibat on native liver survival (NLS) in children with biliary atresia (BA) who have completed study A4250-011 (BOLD)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Completion of the 104-week Treatment Period of Study A4250-011 22. Signed informed consent by the patient’s parent(s) or legal guardian
You likely can't join if
- 1. Patients who were not compliant with study drug treatment or procedures in Study A4250-011 as per the investigator’s discretion 2. Any conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the patient, or interfere with the patient participating in or completing the study 3. Known hypersensitivity to any components of odevixibat 4. Patients who are scheduled for a liver transplant or are likely to require a liver transplant in the immediate future based on the investigator’s judgment
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- Korea, Republic of
- China
- Canada
- Turkey
- Israel
- Taiwan
- United Kingdom
- United States
- Australia
- Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; Korea, Republic of; China; Canada; Turkey; Israel and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.