NCT05295680PHASE2Recruiting

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

Aparna Goel

Start Date

5/10/2023

Completion Date

12/1/2027

Summary

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.

Eligibility Criteria

Age Range: 14 years to 75 years

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

Interventions

DRUG

Hymecromone

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Conditions

Primary Sclerosing Cholangitis

Locations

Stanford Clinic

Redwood City, California 94063

United States

Stanford Clinic

Stanford, California 94305

United States