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Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Recruiting
I'm InterestedTrial 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
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
SPECTRUM
650-498-6060