Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
Active, not recruiting · Phase 3 · NCT05035030
Conditions: Alagille Syndrome
At a glance
- Research payments reported, 2025
- $467,094
- U.S. investigators named
- 11
- Sites paid
- 11
- Planned or actual enrollment
- 62
About the trial
- Sponsor
- Albireo, an Ipsen Company
- Tested
- Odevixibat (drug)
- Dates
- Started 2021-09-03; completion 2027-02-15
- Results posted
- Not yet
The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS). The participants of this study will have ALGS a rare genetic disorder that can affect multiple organ systems of the body including the liver, heart, skeleton, eyes and kidneys. Common symptoms, which often develop during the first three months of life, include blockage of the flow of bile from the liver (cholestasis), yellowing of the skin and mucous membranes (jaundice), poor weight gain and growth and severe itching (pruritis). The drug used for the study is odevixibat and was authorized for the treatment of cholestatic pruritus in infants with ALGS …
From ClinicalTrials.gov, last updated 2026-10-23. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Albireo Pharma, Inc. reported $467,094 in research payments for this study in 2025 (91 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
- Christopher Chu, MD Cardiology · Los Angeles, CA
- Philip Rosenthal, M.D. Pediatrics · San Francisco, CA
- Kyla M. Tolliver, MD Pediatric Gastroenterology · Indianapolis, IN
- Andrew J. Wehrman, M.D. Pediatric Gastroenterology · Boston, MA
- Wikrom Karnsakul, M.D. Pediatric Gastroenterology · Baltimore, MD
- Ryan T. Fischer, MD Pediatric Gastroenterology · Kansas City, MO
- Alisha M. Mavis, MD Pediatric Gastroenterology · Charlotte, NC
- Nadia Ovchinsky Pediatric Gastroenterology · New York, NY
- Saeed Mohammad, MD Pediatric Gastroenterology · Nashville, TN
- Amal A. Aqul, MD Pediatric Gastroenterology · Dallas, TX
- Naveen K. Mittal, MD Pediatric Gastroenterology · Dallas, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Biomedical Research Alliance of New York LLC $97,203
- The University of Texas Southwestern Medical Center $63,635
- The Children's Mercy Hospital, MO $54,324
- Vanderbilt University Medical Center, TN $44,971
- Regents of the University of California at San Diego in La Jolla, California $43,031
- The Trustees of Indiana University $36,566
- American Research Corporation $35,802
- Johns Hopkins University $33,883
- Wake Forest Outpatient Neurology Clinic $30,882
- Boston Children's Hospital, MA $14,267
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $12,530
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.