Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Michael Li, MD, MPH
Headshot of Michael Li
Michael Li

Description

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.

Official Title

A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC)

Details

Global, multi-center longitudinal observational cohort study. Collection of prospective clinical data to include liver-related clinical outcomes and safety events, hepatobiliary malignancies, relevant key biomarkers, imaging assessments, PSC-related clinical symptoms, patient-reported outcomes, and medication use in adult patients with PSC.

Keywords

PSC, Cholangitis, Sclerosing Cholangitis

Eligibility

You can join if…

Open to people ages 18-75

  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 based on current AASLD Guidelines (Bowlus 2023).

You CAN'T join if...

  1. Clinically significant acute or chronic liver disease of an etiology other than PSC (with or without presence of features of AIH).
  2. Small-Duct PSC.
  3. Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.
  4. Clinically diagnosed acute cholangitis and currently receiving treatment. Patients on chronic suppressive antibiotics will be allowed to enroll.
  5. UDCA dose >28 mg/kg
  6. 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)
  7. Prior liver transplantation
  8. MELD-Na Score >15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.
  9. 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 48 weeks.
  10. Participants who are impaired, incapacitated, or incapable of completing study- related assessments or giving informed consent.
  11. Prisoners or participants who are involuntarily incarcerated.
  12. Participants who are currently participating in an interventional clinical study.
  13. Absence of data in medical records to assess inclusion and exclusion criteria.

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • California Pacific Medical Center accepting new patients
    San Francisco California 94109 United States

Lead Scientist at UCSF

  • Michael Li, MD, MPH
    Dr. Michael Li is a transplant hepatologist and gastroenterologist who specializes in caring for patients with cirrhosis, autoimmune liver disease, and liver cancer. Dr. Li’s research focuses on the relationship between the immune system and liver disease. This includes autoimmune diseases like primary sclerosing cholangitis as well as the use of immunotherapy to treat liver cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
PSC Partners Seeking a Cure
ID
NCT06297993
Study Type
Observational
Participants
Expecting 2000 study participants
Last Updated