Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Status:
Not yet recruiting
Trial end date:
2025-05-01
Target enrollment:
Participant gender:
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.