This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
Completed · Phase 3 · Has a placebo group
Conditions studied: PFIC1, PFIC2
In brief
Double blind, randomized, placebo controlled, Phase 3 study to investigate the efficacy and safety of low doses and high doses of A4250 compared to placebo in children with progressive familial intrahepatic cholestasis (PFIC) types 1 and 2.
Key facts
- Study ID
- NCT03566238
- Run by
- Albireo
- People needed
- 62
- Starts
- 2018-05-16
- Expected to finish
- 2020-07-28
- Last updated by the study team
- 2025-11-28
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital Los Angeles — Los Angeles, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Children's Hospital Colorado — Denver, Colorado, United States
- Emory University School of Medicine — Atlanta, Georgia, United States
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Columbia University Medical Center - Presbyterian Hospital Building — New York, New York, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
- Baylor College of Medicine - Texas Children's Liver Center — Houston, Texas, United States
- The Royal Children's Hospital — Melbourne, Australia
- UZ Leuven — Leuven, Belgium
- Cliniques Universitaires Saint-Luc — Woluwe-Saint-Lambert, Belgium
- The Hospital for Sick Children — Toronto, Canada
- British Columbia Children's Hospital — Vancouver, Canada
- University and Pediatric Hospital of Lyon — Bron, France
- Universite Paris SUD - Hopitaux Universitaires Paris-Sud - Hopital Bicetre — Le Kremlin-Bicêtre, France
- Hospital de la Timone — Marseille, France
- Hospital Necker-Enfants maladies — Paris, France
- Uniklinikum Essen- Kinderklinik II — Essen, Germany
- Medizinische Hochschule Hannover — Hanover, Germany
- Kinderklinik Tübingen, Universitätsklinikum Tübingen — Tübingen, Germany
- Rambam Medical Centre — Haifa, Israel
Full record on ClinicalTrials.gov
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