RecruitingNot Applicable

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

United States2,000 participantsStarted 2024-05-06

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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)
✕. 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:
✕. Prior liver transplantation

What they're measuring

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.

Timeframe: Quarterly for five years from enrollment

Trial details

NCT IDNCT06297993

SponsorPSC Partners Seeking a Cure

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-01

Contact for this trial

Stephen Rossi, PharmD

3037715227 stephen@pscpartners.org

View on ClinicalTrials.gov More PSC trials