Actively Recruiting
Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)
Led by PSC Partners Seeking a Cure · Updated on 2026-05-08
2000
Participants Needed
18
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients between 18 and 75 years of age who can understand instructions, follow study procedures, and provide informed consent
- Confirmed clinical diagnosis of large duct Primary Sclerosing Cholangitis (PSC)
You will not qualify if you...
- Presence of significant acute or chronic liver diseases other than PSC, including metabolic dysfunction associated steatohepatitis, primary biliary cholangitis, hepatitis C or B, alcoholic hepatitis, Wilson's disease, alpha-1 antitrypsin deficiency, or drug-induced liver injury
- Diagnosis of Small-Duct PSC
- Diagnosis of secondary or IgG4-related sclerosing cholangitis
- Current infections (including acute cholangitis) treated within the past 7 days; chronic suppressive antibiotic use for acute cholangitis is allowed
- Hospitalization within the past 7 days
- Ursodeoxycholic acid (UDCA) dose exceeding 28 mg/kg
- Evidence of current or past decompensated cirrhosis with severe complications such as ascites requiring treatment, variceal bleeding needing hospitalization, hepatic encephalopathy (West Haven score ≥ 2), spontaneous bacterial peritonitis, acute kidney injury-hepatorenal syndrome, or portal hypertension
- Prior liver transplantation
- MELD 3.0 score greater than 15 (considering anticoagulation medication use for INR calculation)
- History or suspicion of hepatobiliary cancers or active colon cancer, except patients with prior colon cancer who had colectomy and no current cancer
- Severe, progressive, or uncontrolled diseases with expected survival under 52 weeks
- Impairment or incapacity to complete study assessments or give informed consent
- Prisoners or involuntarily incarcerated individuals
- Current participation or recent (within 12 weeks) participation in an investigational PSC therapy clinical trial
- Lack of sufficient medical records to assess eligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
UC Davis
Sacramento, California, United States, 95817
Actively Recruiting
2
California Pacific Medical Center
San Francisco, California, United States, 94109
Actively Recruiting
3
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
5
Schiff Center for Liver Diseases / University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
6
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
8
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Mayo Clinic
Rochester, Minnesota, United States, 55901
Actively Recruiting
10
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
11
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
12
University of Alberta
Edmonton, Alberta, Canada, T6G 2X8
Actively Recruiting
13
University Health Network
Toronto, Ontario, Canada, M5G2C4
Actively Recruiting
14
Centre de recherche du centre hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
15
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
Actively Recruiting
16
University of Milano Bicocca
Milan, Monza (MB), Italy, 20900
Actively Recruiting
17
Auckland University
Auckland, New Zealand
Actively Recruiting
18
Oxford University Hospitals
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
S
Stephen Rossi, PharmD
CONTACT
P
Priya Kannusamy
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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