Observational cohort of adults with primary sclerosing cholangitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This global, multi-center observational cohort study aims to collect prospective clinical data from adult patients diagnosed with primary sclerosing cholangitis (PSC). The study will gather information on liver-related clinical outcomes, safety events, hepatobiliary malignancies, key biomarkers, imaging assessments, PSC-related symptoms, patient-reported outcomes, and medication use. The data collected will serve as a comparator cohort to support the design and execution of future interventional clinical trials in PSC.

Why it matters

Who can join: the full rules

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 suppressive antibiotics for acute cholangitis will be allowed to enroll
5. Hospitalization in the past 7 days
6. UDCA dose \>28 mg/kg
7. 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
8. Prior liver transplantation
9. MELD 3.0 Score \>15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.
10. 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.
11. 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.
12. Participants who are impaired, incapacitated, or incapable of completing study-related assessments or giving informed consent.
13. Prisoners or participants who are involuntarily incarcerated.
14. 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
15. Absence of data in medical records to assess inclusion and exclusion criteria.

Where it's running

• UC Davis
  Sacramento, California, United States Recruiting
• California Pacific Medical Center
  San Francisco, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Schiff Center for Liver Diseases / University of Miami
  Miami, Florida, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Cynthia Levy, MD — University of Miami
• Study coordinator: Stephen Rossi, PharmD
• Email: stephen@pscpartners.org
• Phone: 3037715227

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Preventing recurrence of primary sclerosing cholangitis after liver transplantation

  This study is testing if a daily medication called fenofibrate can help prevent primary sclerosing cholangitis from coming back in people who have had a liver transplant.

  Recruiting Phase 2 Mayo Clinic · Scottsdale, Arizona · NCT06905054

• Colangioids to find genetic causes of atypical primary sclerosing cholangitis

  This project will use lab-grown bile duct organoids (colangioids) to test which genetic changes are linked to atypical primary sclerosing cholangitis in adults with confirmed or suspected PSC or in available liver tissue.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan, MI · NCT06865924

• Collecting bile samples from patients with Primary Sclerosing Cholangitis and controls

  This study is collecting bile samples from people with Primary Sclerosing Cholangitis and healthy individuals to see how the disease affects the body and find new ways to treat it.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT04753996

• Swiss Primary Sclerosing Cholangitis Cohort

  This project will collect blood and other biological samples plus health information from people with primary sclerosing cholangitis in Switzerland to try to better understand the disease course and treatment responses.

  Recruiting at 21 sites Fondazione Epatocentro Ticino · Lugano, Canton Ticino and 20 other locations · NCT03146936

• Biodegradable stents for high-grade bile duct strictures in PSC

  This study tests whether placing biodegradable stents helps open tight bile duct strictures in people with primary sclerosing cholangitis.

  Recruiting King's College Hospital NHS Trust · London · NCT07607353

• Vancomycin for active ulcerative colitis with primary sclerosing cholangitis

  This study tests whether oral vancomycin can help adults with both ulcerative colitis and primary sclerosing cholangitis more than a placebo over four weeks.

  Recruiting Phase 2 McMaster University · Hamilton, Ontario · NCT07341282

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.