🏛️ Verified NIH Record • Updated 2026-06-24
Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study) (NCT06297993)
🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: PSC Partners Seeking a Cure
🩺 Plain-English Summary (8th-Grade Level)
Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (24 items).
Location: UC Davis — Sacramento, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Clinically significant acute or chronic liver disease of an etiology other than PSC (including but not limited to metabolic-dysfunction associated steatohepatitis (MASH), PBC, HCV, HBV, or alcoholic hepatitis, Wilson's disease, alpha-1 antitryp-sin deficiency, acute or chronic drug-induced liver injury)
- Patients with PSC and elements of AIH overlap are allowed to enroll
- Patients with metabolic dysfunction associated steatotic liver disease (MASLD) or benign steatosis are allowed to enroll
- Small-Duct PSC.
- Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.
- Clinically diagnosed infections (including acute cholangitis) and receiving treatment within the past 7 days; patients on chronic suppressive antibiotics for acute cholangitis will be allowed to enroll
- Hospitalization in the past 7 days
- UDCA dose \>28 mg/kg
- Evidence of current or historical decompensated cirrhosis based on the following clinical events:
- Ascites \> Grade 2 and requiring treatment
- Esophageal or gastric variceal bleeding requiring hospitalization
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (18 Sites)
- UC Davis — Sacramento, California
- California Pacific Medical Center — San Francisco, California
- University of California, San Francisco — San Francisco, California
- Yale University — New Haven, Connecticut
- Schiff Center for Liver Diseases / University of Miami — Miami, Florida
- Indiana University — Indianapolis, Indiana
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- UT Southwestern Medical Center — Dallas, Texas
- Virginia Commonwealth University — Richmond, Virginia
- University of Alberta — Edmonton, Alberta
- University Health Network — Toronto, Ontario
- Centre de recherche du centre hospitalier de l'Université de Montréal (CRCHUM) — Montreal, Quebec
- University Medical Center Hamburg-Eppendorf — Hamburg, Free and Hanseatic City of Hamburg
- University of Milano Bicocca — Milan, Monza (MB)
- Auckland University — Auckland,
- Oxford University Hospitals — Oxford,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.