A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD) (Liver Disease)
| Sponsor: |
Albireo |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
AAAS9228 |
| U.S. Govt. ID: |
NCT04336722 |
| Contact: |
Transplant Clinical Research Center - TCRC: / tcrcstudyreferral@cumc.columbia.edu |
This study evaluates whether odevixibat is safe and effective compared to placebo in children with biliary atresia who have recently undergone a Kasai procedure. This is a double-blind study, so the study doctors and the child/parent will not know whether the child is receiving odevixibat or placebo. Participation will involve several research visits over approximately a 2 year period. After completion of the study, participants may be eligible to join an extension study to receive "open-label" odevixibat through the study. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
This study is closed
Investigator
Dana Goldner, MD
| Is your child diagnosed with Biliary Atresia (BA)? |
Yes |
No |
| Has your child undergone a Kasai HPE procedure? |
Yes |
No |