Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.

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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:

Primary Sclerosing Cholangitis

Study Start (Actual) 2023-05-10

Primary Completion (Estimated) 2025-05

Study Completion (Estimated) 2025-05

Enrollment (Estimated) 24

Study Type INTERVENTIONAL

Phase PHASE2

Locations:

📍 Redwood City, California, United States

📍 Stanford, California, United States

Eligibility Criteria

Description

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

Ages Eligible for Study: 14 Years to 75 Years (CHILD, ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2022-03-04
First Submitted that Met QC Criteria2022-03-15
First Posted2022-03-25

Study Record Updates

Last Update Submitted that Met QC Criteria2023-10-04
Last Update Posted2023-10-06
Last Verified2023-10