Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)
This study is collecting health information from adults with primary sclerosing cholangitis (PSC) around the world to better understand how the disease progresses in real life. The information gathered will help researchers design and compare future treatment trials for PSC.
Key Objective: This study helps advance PSC research by creating a detailed database of patient experiences that can be used to test new treatments more effectively.
Who to Consider: Adults diagnosed with primary sclerosing cholangitis who want to contribute to research that may help develop better treatments for the disease.
Trial Parameters
Brief 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 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 supp