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

Recruiting now · Phase 2

Conditions studied: Primary Sclerosing Cholangitis

In brief

Primary objective: To evaluate the efficacy of hymecromone plus standard of care compared with standard of care alone in the treatment of adolescents and adults with primary sclerosing cholangitis (PSC). Secondary objectives: To evaluate the change in Alkaline Phosphatase (ALP) from baseline to 6 months post-treatment following treatment with hymecromone plus standard of care compared with standard of care. To evaluate changes in biomarkers of PSC disease during hymecromone treatment, namely: (a) fibrotic effect (FibroScan); (b) inflammatory biomarkers (serum Hyaluronan (HA)); and, (c) T-cell count.

Key facts

Study ID

NCT05295680

Run by

Aparna Goel

People needed

24

Starts

2023-05-10

Expected to finish

2027-12-01

Last updated by the study team

2025-06-13

Who can join

Age: 14 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Currently receiving biologic therapies
• Known allergy to hymecromone
• Cholangiocarcinoma
• Pregnancy
• Serious liver disease

Where it is running

• Stanford Clinic — Redwood City, California, United States (enrolling)
• Stanford Clinic — Stanford, California, United States (enrolling)

Full record on ClinicalTrials.gov

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