Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.
Recruiting
Phase 2
Interventional Study
Primary Sclerosing Cholangitis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 14 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Aparna Goel · Other
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About This Trial
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 standa…
Trial Locations
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Eligibility Criteria
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 inflamma…
Contacts
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