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) (Peds)
Study of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
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
Additional Study Information: 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
Do You Qualify?
Is your child diagnosed with Biliary Atresia (BA)? Yes No
Has your child undergone a Kasai HPE procedure? Yes No
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For more information, please contact:
Transplant Clinical Research Center - TCRC
tcrcstudyreferral@cumc.columbia.edu