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Observational cohort of adults with primary sclerosing cholangitis

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

Observational PSC Partners Seeking a Cure · NCT06297993

This study is collecting health information from adults with primary sclerosing cholangitis to help understand the condition better and improve future treatments.

Quick facts

Study typeObservational
Enrollment2000 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorPSC Partners Seeking a Cure Academic / other
Locations18 sites (Sacramento, California and 17 other locations)
Trial IDNCT06297993 on ClinicalTrials.gov

What this trial studies

This global, multi-center observational cohort study aims to collect prospective clinical data from adult patients diagnosed with primary sclerosing cholangitis (PSC). The study will gather information on liver-related clinical outcomes, safety events, hepatobiliary malignancies, key biomarkers, imaging assessments, PSC-related symptoms, patient-reported outcomes, and medication use. The data collected will serve as a comparator cohort to support the design and execution of future interventional clinical trials in PSC.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of large duct primary sclerosing cholangitis.

Not a fit: Patients with small-duct PSC or other significant liver diseases unrelated to PSC may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable real-world data that enhances the understanding and treatment of primary sclerosing cholangitis.

How similar studies have performed: While this approach is observational and may not have direct precedents, similar studies in other chronic liver diseases have successfully utilized real-world data to inform clinical practices.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Sacramento, California and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions PSC
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.