Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Trial ID or NCT#
Status
NOT RECRUITING
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).
Eligibility 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
- - Currently receiving biologic therapies - Known allergy to hymecromone - Cholangiocarcinoma - Pregnancy - Serious liver disease
Investigator(s)
View on ClinicalTrials.gov