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Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Sponsor: Aparna Goel
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.
Official title: A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).
Key Details
Gender
All
Age Range
14 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2023-05-10
Completion Date
2027-12
Last Updated
2025-06-13
Healthy Volunteers
No
Conditions
Interventions
Hymecromone
Hymecromone 400 mg 3 times daily by mouth.
Locations (2)
Stanford Clinic
Redwood City, California, United States
Stanford Clinic
Stanford, California, United States