Ireland
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Latest
Recruiting Observational

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

NCT06297993 · tracked via the Priya Life Science Italy tracker
Sponsor
PSC Partners Seeking a Cure
Phase
Observational
Started
2024-05-06
Last updated
2026-09-08

Condition(s) studied

PSC

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (18)

FacilityCityRegionStatus
UC Davis Sacramento California Recruiting
California Pacific Medical Center San Francisco California Recruiting
University of California, San Francisco San Francisco California Recruiting
Yale University New Haven Connecticut Recruiting
Schiff Center for Liver Diseases / University of Miami Miami Florida Recruiting
Indiana University Indianapolis Indiana Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Mayo Clinic Rochester Minnesota Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
Virginia Commonwealth University Richmond Virginia Recruiting
University of Alberta Edmonton Alberta Recruiting
University Health Network Toronto Ontario Recruiting
Centre de recherche du centre hospitalier de l'Université de Montréal (CRCHUM) Montreal Quebec Recruiting
University Medical Center Hamburg-Eppendorf Hamburg Free and Hanseatic City of Hamburg Recruiting
University of Milano Bicocca Milan Monza (MB) Recruiting
Auckland University Auckland New Zealand Recruiting
Oxford University Hospitals Oxford United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06297993 on ClinicalTrials.gov ↗ ← All trials in Italy