WIND-PSC Study
Research type
Research Study
Full title
A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients with Primary Sclerosing Cholangitis (WIND-PSC Study)
IRAS ID
352827
Contact name
Emma Culver
Contact email
Sponsor organisation
PSC Partners Seeking a Cure
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
PSC is a rare liver disease that currently does not have FDA-approved therapies. The placebo arm of drug trials is difficult to recruit for in rare disease trials. The WIND-PSC study was designed to meet FDA and European regulatory guidance for real world data to be used as a placebo arm in drug studies.
Participants from age 18 to 75 years of age with large duct PSC will participate at PSC research centers across North America and Europe. Participation includes a baseline in-person visit, one in-person visit each year, and three remote visits yearly, over the 5 years of participation. During their participation, at each visit, participants will answer questions about their PSC, allow coordinators to review medical records for clinical information, and complete Patient Reported Outcomes Measures questionnaires. At in-person visits participants will donate blood samples for extraction of serum and plasma for use in future studies.REC name
South West - Frenchay Research Ethics Committee
REC reference
25/SW/0154
Date of REC Opinion
21 Jan 2026
REC opinion
Further Information Favourable Opinion