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

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Trial ID: NCT05295680

Purpose

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.

Official Title

A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).

Stanford Investigator(s)

Aparna Goel

Clinical Associate Professor, Medicine - Gastroenterology & Hepatology

Eligibility


Inclusion Criteria:

   - 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 Criteria:

   - Currently receiving biologic therapies

   - Known allergy to hymecromone

   - Cholangiocarcinoma

   - Pregnancy

   - Serious liver disease

Intervention(s):

drug: Hymecromone

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
SPECTRUM
650-498-6060