Status:
RECRUITING
Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Lead Sponsor:
Aparna Goel
Conditions:
Primary Sclerosing Cholangitis
Eligibility:
All Genders
14-75 years
Phase:
PHASE2
Brief 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 (PS...
Eligibility Criteria
Inclusion
- 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
- Currently receiving biologic therapies
- Known allergy to hymecromone
- Cholangiocarcinoma
- Pregnancy
- Serious liver disease
Key Trial Info
Start Date :
May 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05295680
Start Date
May 10 2023
End Date
December 1 2027
Last Update
June 13 2025
Active Locations (2)
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1
Stanford Clinic
Redwood City, California, United States, 94063
2
Stanford Clinic
Stanford, California, United States, 94305