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WIND-PSC Study for Primary Sclerosing Cholangitis

This study, called WIND-PSC, is looking for adults with primary sclerosing cholangitis (PSC) to join. PSC is a rare, chronic liver disease that damages the bile ducts. This is an observational study, meaning researchers will collect information about your health over time without testing a specific drug or treatment. The goal is to create a large database of real-world information about PSC. This database will help design future studies and serve as a comparison for new treatments being tested. You may be able to join if you are between 18 and 75 years old and have a confirmed diagnosis of large duct PSC. The study aims to enroll 2000 participants.

Study design
This is a global, multi-center observational study. It plans to enroll 2000 adult participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed quarterly for five years from enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06297993

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

Recruiting
Not specifiedAges 18–75Observational
PSC Partners Seeking a Cure
~2,000 participants
Updated 2026-06-29 on ClinicalTrials.gov

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Quarterly for five years from enrollment

Conditions

PSC

Explore related trials

Primary Sclerosing Cholangitis

Where it's being run

18 sites across 15 states
California3
Massachusetts2
Connecticut1
Florida1
Indiana1
Minnesota1
Texas1
Virginia1

Study leadership

  • Cynthia Levy, MD · PRINCIPAL_INVESTIGATOR · University of Miami
  • Stephen Rossi, PharmD · PRINCIPAL_INVESTIGATOR · PSC Partners Seeking a Cure

Who to contact

Stephen Rossi, PharmD
[email protected]
3037715227
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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

What this trial measures

  • 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.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.