Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Completed · Phase 3 · NCT04336722
Conditions: Biliary Atresia
At a glance
- Research payments reported, 2025
- $504,808
- U.S. investigators named
- 25
- Sites paid
- 26
- Planned or actual enrollment
- 254
About the trial
- Sponsor
- Albireo, an Ipsen Company
- Tested
- Odevixibat (drug), Placebo (drug)
- Dates
- Started 2020-07-08; completion 2026-06-22
- Results posted
- Not yet
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.
From ClinicalTrials.gov, last updated 2026-07-02. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Albireo Pharma, Inc. reported $504,808 in research payments for this study in 2025 (166 payments).
Products named: Bylvay
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Laura E. Bauman, M.D. Pediatric Gastroenterology · San Diego, CA
- Rohit Kohli, MBBS, MS Pediatric Gastroenterology · Los Angeles, CA
- Amrita Narang, MD Pediatric Gastroenterology · Palo Alto, CA
- Philip Rosenthal, M.D. Pediatrics · San Francisco, CA
- Shikha Sundaram, MD Pediatric Gastroenterology · Aurora, CO
- Adebowale A. Adeyemi, MD Pediatric Gastroenterology · Wilmington, DE
- Jennifer Garcia, MD Pediatric Gastroenterology · Miami, FL
- Reuven Zev Cohen, MD Pediatric Gastroenterology · Atlanta, GA
- Alyssa A. Kriegermeier, M.D. Pediatric Gastroenterology · Chicago, IL
- Eugenia P. Molleston, MD Pediatric Gastroenterology · Indianapolis, IN
- Andrew J. Wehrman, M.D. Pediatric Gastroenterology · Boston, MA
- Maclovio J. Lopez, MD, PHD Pediatric Gastroenterology · Ann Arbor, MI
- Victoria Shakhin, M.D. Pediatric Gastroenterology · Ann Arbor, MI
- Ryan T. Fischer, MD Pediatric Gastroenterology · Kansas City, MO
- Janis M. Stoll, MD Pediatric Gastroenterology · Saint Louis, MO
- Amanda L. Cantor, MD Pediatric Gastroenterology · New York, NY
- Jaime Chu, M.D. Pediatric Gastroenterology · New York, NY
- Nadia Ovchinsky Pediatric Gastroenterology · New York, NY
- Michael E. Rogers, D.O. Pediatric Gastroenterology · Cincinnati, OH
- Henry C. Lin, MD Pediatric Gastroenterology · Portland, OR
- Kathleen M. Loomes, M.D. Pediatric Gastroenterology · Philadelphia, PA
- James Squires Pediatric Gastroenterology · Pittsburgh, PA
- Amal A. Aqul, MD Pediatric Gastroenterology · Dallas, TX
- Michael K. Jensen, M.D. Pediatrics · Salt Lake City, UT
- Evelyn K. Hsu, M.D. Pediatric Gastroenterology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Stanford University $69,183
- Children's Hospital Colorado, CO $61,272
- Cincinnati Children's Hospital Medical Center, OH $52,604
- Washington University School of Medicine $36,160
- Biomedical Research Alliance of New York LLC $33,788
- $25,995
- University of Michigan Health System, MI $23,555
- Nemours Children's Hospital, Delaware, DE $23,195
- Regents of the University of California at San Diego in La Jolla, California $21,337
- Childrens Healthcare of Atlanta Inc $18,366
- The University of Texas Southwestern Medical Center $18,174
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $16,548
- Children's Hospital of Philadelphia, PA $15,796
- University of Utah Hospital and Clinics, UT $14,812
- The Children's Mercy Hospital, MO $13,085
- University of Pittsburgh Physicians Department of Neurology $11,286
- University of Pittsburgh Medical Center $11,223
- Children's Hosp of Los Angeles, CA $8,272
- The Trustees of Columbia University in The City of New York $7,454
- University of Miami Medical Grp $5,546
- University of Miami $4,172
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $3,550
- The Trustees of Indiana University $2,750
- Mount Sinai School of Medicine Urology $2,536
- Ohsu Hospital and Clinics, OR $1,662
- Seattle Children's Hospital, WA $1,602
- Boston Children's Hospital, MA $885
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.