Actively Recruiting
A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC)
Led by PSC Partners Seeking a Cure · Updated on 2026-05-08
2000
Participants Needed
18
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a global, multi-center observational study to collect real-world data from adult patients diagnosed with large duct Primary Sclerosing Cholangitis (PSC). The goal is to develop a comprehensive dataset that can support the design and execution of future clinical trials for PSC by serving as an external control group. This study is sponsored by PSC Partners Seeking a Cure and aims to gather detailed clinical and biomarker information over time. Participants in this study will not receive experimental treatments but will have their health tracked through regular clinical assessments. Data collected includes liver-related outcomes, safety events, occurrences of hepatobiliary cancers, key biomarkers, imaging results, PSC symptoms, patient-reported outcomes, and medication use. Information is gathered quarterly for up to five years after enrollment. Throughout the study, participants will complete standardized questionnaires and undergo various clinical evaluations to monitor their condition and disease progression. Researchers will analyze these data to identify potential surrogate endpoints and better understand the disease course. Participation involves regular follow-up visits every three months, during which clinical data and patient experiences will be recorded to support drug development efforts in PSC.
CONDITIONS
Brief 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...
- Adults aged 18 to 75 years who can understand instructions and follow study procedures
- Willingness to sign an Informed Consent Form
- Confirmed clinical diagnosis of large duct Primary Sclerosing Cholangitis (PSC)
You will not qualify if you...
- Acute or chronic liver diseases other than PSC, such as MASH, PBC, hepatitis C or B, alcoholic hepatitis, Wilson's disease, alpha-1 antitrypsin deficiency, or drug-induced liver injury
- Small-duct PSC
- Secondary or IgG4-related sclerosing cholangitis
- Current infections or treatment for infections within the past 7 days (except chronic suppressive antibiotics for cholangitis)
- Hospitalization in the past 7 days
- Ursodeoxycholic acid dose greater than 28 mg/kg
- Evidence of current or past decompensated cirrhosis with complications like severe ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, acute kidney injury-hepatorenal syndrome, or portal hypertension
- Prior liver transplantation
- MELD 3.0 score greater than 15 (adjusted for anticoagulation use)
- History or suspicion of hepatobiliary cancers or active colon cancer (except patients post-colectomy with no current cancer)
- Presence of any severe, progressive, or uncontrolled disease with expected survival under 52 weeks
- Inability to provide informed consent or complete study assessments
- Prisoners or involuntarily incarcerated individuals
- Participation in another investigational PSC therapy trial within the past 12 weeks
- Lack of sufficient medical records to assess eligibility
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years from enrollment
Participants with a confirmed diagnosis of large duct Primary Sclerosing Cholangitis (PSC) are observed over time to collect clinical data, biomarkers, imaging assessments, symptoms, patient-reported outcomes, and medication use.
Quarterly visits for up to 5 years
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
P
Priya Kannusamy
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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