Clinical Trial: A Study of Oral Hymecromone to Treat Adults With Primary Sclerosing Cholangitis
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Pilot Study of Oral Hymecromone to Treat Adults With Primary Sclerosing Cholangitis
Brief Summary: Primary sclerosing cholangitis (PSC) is a chronic inflammatory disease of the biliary ducts in the liver resulting in destruction and fibrosis. PSC is associated with increased serum levels of hyaluronan (HA), an extracellular matrix polymer known to drive inflammation in multiple other tissues and disease models. Inhibition of HA synthesis with oral hymecromone has been shown to prevent progression of autoimmunity in several animal models. This is a prospective, open-label, single-center, pilot safety study of hymecromone in adults 18 years of age or older diagnosed with primary sclerosing cholangitis without evidence of hepatic fibrosis. Participants will be treated for 6 months with study drug. Safety and biomarkers of response will be monitored during therapy.
Detailed Summary:
Sponsor: Stanford University
Current Primary Outcome: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months (6 months on treatment and 6 months post treatment) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of participants with a qualitative improvement in the anatomy of the biliary tree as assessed by Magnetic Resonance Cholangiopancreatography [ Time Frame: Month 0 (baseline) and Month 6 ]
- Hyaluronan serum levels [ Time Frame: Month 0 (baseline) and 3 ]
- Hymecromone drug levels [ Time Frame: Month 3 and Month 6 ]
- Number of participants with gamma-glutamyl transferase <1.5 times the upper limit of normal [ Time Frame: Month 0 (baseline), 3, 6, 9, 12 ]
- Number of participants with Alkaline phosphatase <1.5 times the upper limit of normal [ Time Frame: Month 0 (baseline), 3, 6, 9, 12 ]
Original Secondary Outcome: Same as current
Information By: Stanford University
Dates:
Date Received: May 17, 2016
Date Started: July 2016
Date Completion:
Last Updated: May 20, 2016
Last Verified: May 2016