Actively Recruiting

Age: 18Years - 75Years
All Genders
NCT06297993

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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

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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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Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study) | DecenTrialz