Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis
Completed · Phase 1
Conditions studied: Cholangitis, Sclerosing
In brief
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%.
Key facts
- Study ID
- NCT01456468
- Run by
- Yale University
- People needed
- 19
- Starts
- 2011-10-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2016-07-14
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of PSC for at least 6 months, made by clinical evaluation in addition to one of the following: a prior endoscopic retrograde cholangiography (ERC), magnetic resonance cholangiography (MRC, also termed MRI/MRCP) or liver biopsy.
- Progressing disease or stable disease with persistent elevation in AP despite treatment with UDCA (15 mg/kg/day) for at least 6 months.
- Measures of progressing disease:
- Cholangitis within the past 12 months.
- Presence or progression of biliary abnormalities on MRI/MRC.
- Elevated liver tests (alkaline phosphatase, bilirubin, aspartate aminotransferase [AST], alanine aminotransferase [ALT]).
- Age between 18 and 80.
You may not qualify if…
- Pregnancy or planned pregnancy during study period and within 6 months of study completion.
- Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher cardiac disease, hyperlipidemia, hypertriglyceridemia, hepatic injury, or adverse event related to administration of UDCA or ATRA.
- Prior intolerance to UDCA or ATRA (or related oral vitamin A compounds).
- Evidence of decompensated cirrhosis within the past 6 months (i.e. variceal bleeding, uncontrolled ascites, hepatic encephalopathy, jaundice).
- Estimated need for liver transplantation within 1 year.
- Any evidence of hepatocellular carcinoma, cholangiocarcinoma, or other malignancy.
Where it is running
- Yale University School of Medicine - 333 Cedar St - 1080 LMP — New Haven, Connecticut, United States
- Mayo Clinic — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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