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

May 4, 2026 updated by: PSC Partners Seeking a Cure

A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC)

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Global, multi-center longitudinal observational cohort study. Collection of prospective clinical data to include liver-related clinical outcomes and safety events, hepatobiliary malignancies, relevant key biomarkers, imaging assessments, PSC-related clinical symptoms, patient-reported outcomes, and medication use in adult patients with PSC.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • Recruiting
        • University of Alberta
        • Contact:
        • Principal Investigator:
          • Aldo Montano-Loza, MD, MSc, PhD, FAASLD, FACG
    • Ontario
      • Toronto, Ontario, Canada, M5G2C4
        • Recruiting
        • University Health Network
        • Principal Investigator:
          • Gideon Hirschfield, FRCP,MD
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
        • Principal Investigator:
          • Julian Hercun, MD
        • Contact:
  • Germany
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20246
        • Recruiting
        • University Medical Center Hamburg-Eppendorf
        • Contact:
        • Principal Investigator:
          • Christoph Schramm, Prof. Dr.
  • Italy
    • Monza (MB)
      • Milan, Monza (MB), Italy, 20900
  • New Zealand
      • Auckland, New Zealand
        • Recruiting
        • Auckland University
        • Contact:
        • Principal Investigator:
          • Hannah Giles, MBChB, FRACP
  • United Kingdom
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford University Hospitals
        • Contact:
        • Principal Investigator:
          • Emma Culver, BSc (Hons), MBChB, MRCP, DPhil
  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis
        • Principal Investigator:
          • Christopher Bowlus, MD
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Michael Li, MD, MPH
      • San Francisco, California, United States, 94109
        • Recruiting
        • California Pacific Medical Center
        • Principal Investigator:
          • Kidist Yimam, MD
        • Contact:
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Marina Silveira, MD
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • Schiff Center for Liver Diseases / University of Miami
        • Principal Investigator:
          • Cynthia Levy, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Craig Lammert, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Daniel Pratt, MD
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Vilas Patwardhan, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55901
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • John Eaton, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Principal Investigator:
          • Marlyn Mayo, MD
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Obi Aseem, MD
        • Sub-Investigator:
          • Velimir Luketic, MD
        • Sub-Investigator:
          • Amon Asgharpour, MD
        • Sub-Investigator:
          • Shadab Siddiqui, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

2000 adult participants with confirmed diagnosis of large duct PSC

Description

Inclusion Criteria:

  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.

Exclusion Criteria:

  1. 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
  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
  15. Absence of data in medical records to assess inclusion and exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop an appropriate real-world data (RWD) comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.
Time Frame: Quarterly for five years from enrollment
Collection of liver-related data including PSC symptoms, medical history, adverse events, and outcomes at enrollment and each quarterly and annual visit.
Quarterly for five years from enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop a large clinical and biomarker data set to identify individual and/or composite surrogate end-points likely to predict clinical benefit for use in the design of interventional studies in PSC.
Time Frame: Quarterly for five years from enrollment
Collection of biomarkers at enrollment and each annual visit.
Quarterly for five years from enrollment
Develop a large clinical and biomarker data set to identify individual and/or composite surrogate end-points likely to predict clinical benefit for use in the design of interventional studies in PSC.
Time Frame: Quarterly for five years from enrollment
Collection of imaging at enrollment and each annual visit.
Quarterly for five years from enrollment
Evaluate direct participant experiences with standardized tools to determine changes over time, the association with clinical events, biomarkers, and disease progression
Time Frame: Quarterly for five years from enrollment
Patient Reported Outcomes surveys will be collected from all participants at enrollment and each quarterly and annual visit.
Quarterly for five years from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PSC Partners Seeking a Cure

Investigators

  • Principal Investigator: Cynthia Levy, MD, University of Miami
  • Principal Investigator: Stephen Rossi, PharmD, PSC Partners Seeking a Cure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2031

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIND-PSC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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