Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)
NCT ID: NCT06297993
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2024-05-06
2031-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Adult patients with a confirmed diagnosis of large duct PSC.
1. Adult patients between 18 and 75 years of age (inclusive) who can comprehend instructions, follow the study procedures and are willing to sign an Informed Consent Form (ICF).
2. Confirmed clinical diagnosis of large duct PSC
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Confirmed clinical diagnosis of large duct PSC.
Exclusion Criteria
* 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
2. Small-Duct PSC.
3. Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.
4. 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
5. Hospitalization in the past 7 days
6. UDCA dose \>28 mg/kg
7. 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
* Hepatic encephalopathy (as defined by a West Haven score ≥ 2)
* Spontaneous bacterial peritonitis defined as ascites absolute neutrophil count \>250/mm3 in the absence of an intra-abdominal source of infection
* AKI-HRS according to AASLD Guidelines (Flamm 2021)
* Portal hypertension based on a platelet count \< 150 × 109/L and LSM \> 15 kPa with clinical, laboratory, imaging and/or other relevant parameters
8. Prior liver transplantation
9. MELD 3.0 Score \>15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.
10. History, evidence, or high suspicion of hepatobiliary malignancies or active colon cancer based on imaging, screening laboratory values, and/or clinical symptoms. Patients with a history of colon cancer who have undergone a colectomy and have no current evidence of colon cancer will be allowed to enroll in the study.
11. Participants with current clinical or laboratory evidence of any severe, progressive, or uncontrolled disease, related or unrelated to PSC and which, in the opinion of the investigator, has an expected survival of less than 52 weeks.
12. Participants who are impaired, incapacitated, or incapable of completing study-related assessments or giving informed consent.
13. Prisoners or participants who are involuntarily incarcerated.
14. Participants who are currently participating in an investigational PSC therapy clinical study or who have participated in such a study within the past 12 weeks
18 Years
75 Years
ALL
No
Sponsors
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PSC Partners Seeking a Cure
OTHER
Responsible Party
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Principal Investigators
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Cynthia Levy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Stephen Rossi, PharmD
Role: PRINCIPAL_INVESTIGATOR
PSC Partners Seeking a Cure
Locations
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UC Davis
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Schiff Center for Liver Diseases / University of Miami
Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Alberta
Edmonton, Alberta, Canada
University Health Network
Toronto, Ontario, Canada
University Medical Center Hamburg-Eppendorf
Hamburg, Hamburg, Germany
University of Milano Bicocca
Milan, Monza (MB), Italy
Auckland University
Auckland, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WIND-PSC-01
Identifier Type: -
Identifier Source: org_study_id
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