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

Recruiting now

Conditions studied: PSC

In brief

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.

Key facts

Study ID

NCT06297993

Run by

PSC Partners Seeking a Cure

People needed

2000

Starts

2024-05-06

Expected to finish

2031-01-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Confirmed clinical diagnosis of large duct PSC.

You may not qualify if…

• 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
• Small-Duct PSC.
• Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.
• 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
• Hospitalization in the past 7 days
• UDCA dose >28 mg/kg
• 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
• Prior liver transplantation
• MELD 3.0 Score >15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.
• 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.
• 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.
• Participants who are impaired, incapacitated, or incapable of completing study-related assessments or giving informed consent.
• Prisoners or participants who are involuntarily incarcerated.
• 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
• Absence of data in medical records to assess inclusion and exclusion criteria.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.