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Massive PSC study aims to create blueprint for faster drug trials

NCT ID NCT06297993

Knowledge-focused Sponsor: PSC Partners Seeking a Cure Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 4 times

Summary

This study is gathering health information from 2,000 adults with primary sclerosing cholangitis (PSC) to build a real-world data comparator group. The goal is to help design and run future drug trials more efficiently by providing a control group from real patient experiences. Participants will share medical history, symptoms, and biomarkers over quarterly and annual visits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

2000 adult participants with confirmed diagnosis of large duct PSC

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

pancreatic serous cystadenoma primary sclerosing cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PSC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Auckland University

    RECRUITING

    Auckland, New Zealand

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • California Pacific Medical Center

    RECRUITING

    San Francisco, California, 94109, United States

  • Centre de recherche du centre hospitalier de l'Université de Montréal (CRCHUM)

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55901, United States

  • Oxford University Hospitals

    RECRUITING

    Oxford, OX3 9DU, United Kingdom

  • Schiff Center for Liver Diseases / University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • UC Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G2C4, Canada

  • University Medical Center Hamburg-Eppendorf

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, 20246, Germany

  • University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2X8, Canada

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Milano Bicocca

    RECRUITING

    Milan, Monza (MB), 20900, Italy

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

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