Hymecromone for Primary Sclerosing Cholangitis

This study is looking at whether an oral medication called Hymecromone can help adolescents and adults with Primary Sclerosing Cholangitis (PSC). PSC is a chronic liver disease that damages the bile ducts. Researchers want to see if taking Hymecromone 400 mg three times a day, along with your usual care, is more effective than just usual care alone. The main way they will measure success is by checking changes in a liver enzyme called gamma-glutamyltransferase (GGT) in your blood over six months. They will also look at other liver markers and signs of inflammation. You may be able to join if you are between 14 and 75 years old and have a confirmed diagnosis of PSC. The study plans to enroll 24 participants, but its current status is unclear.

Study design
This is an interventional study comparing Hymecromone plus standard care to standard care alone. It plans to enroll 24 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured from baseline to Month 6, suggesting a follow-up period of at least six months.

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NCT05295680

Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.

Recruiting
PHASE2Ages 14–75InterventionalTreatment
Aparna Goel
~24 participants
Updated 2025-06-13 on ClinicalTrials.gov
What's tested:Hymecromone

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in serum gamma-glutamyltransferase (GGT) levels
Measured over Baseline to Month 6
Primary Sclerosing Cholangitis
2 sites across 1 states
California2
  • Aparna Goel, MD · PRINCIPAL_INVESTIGATOR · Stanford University
  • Leina Alrabadi, MD · PRINCIPAL_INVESTIGATOR · Stanford University

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and/or imaging study
If history of endoscopically confirmed inflammatory bowel disease, currently stable based on Mayo Score / Disease Activity Index (DAI) for Ulcerative Colitis Score ≤ 1, normal inflammatory markers (ESR, CRP and fecal calprotectin) and stable non-excluded medical therapy for at least 6 months

Exclusion

Currently receiving biologic therapies
Known allergy to hymecromone
Cholangiocarcinoma
Pregnancy
Serious liver disease
  • Change in serum gamma-glutamyltransferase (GGT) levelsBaseline to Month 6