Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Paul Bollyky

Stanford Investigator(s):

Intervention(s):

  • Drug: Hymecromone

Phase:

Phase 2

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

Ages Eligible for Study

14 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting