drugset / Trial / NCT01456468

Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis

NCT01456468

Phase 1 Completed 19 enrolled Yale University Mayo Clinic · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to determine whether the combination of UDCA and ATRA taken for 3 months will improve laboratory tests of liver and bile duct inflammation in patients with Primary Sclerosing Cholangitis (PSC). Our hypothesis is that a combination of these medications will improve the liver inflammatory tests in these patients, specifically a reduction in alkaline phosphatase (AP) by at least 30%.

Timeline

Start
2011-10
Primary completion
2014-06
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tretinoin Small molecule 45 mg/m2 Oral