Actively Recruiting
Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Led by Aparna Goel · Updated on 2025-06-13
24
Participants Needed
2
Research Sites
238 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Stable non-excluded medical therapy for at least 6 months
You will not qualify if you...
- Currently receiving biologic therapies
- Known allergy to hymecromone
- Cholangiocarcinoma
- Pregnancy
- Serious liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Stanford Clinic
Redwood City, California, United States, 94063
Actively Recruiting
2
Stanford Clinic
Stanford, California, United States, 94305
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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