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).
Investigator
Dana Goldner, MD
Is your child diagnosed with Biliary Atresia (BA)? |
Yes |
No |
Has your child undergone a Kasai HPE procedure? |
Yes |
No |