Status:
COMPLETED
Combination Therapy With Ursodeoxycholic Acid (UDCA) and All-Trans Retinoic Acid (ATRA) for Treatment of Primary Sclerosing Cholangitis
Lead Sponsor:
Yale University
Collaborating Sponsors:
Mayo Clinic
Conditions:
Cholangitis, Sclerosing
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 Primar...
Detailed Description
Patients with PSC often have ongoing inflammation and fibrosis (scars) along the length of their bile ducts, and eventually this involves the liver itself which can lead to cirrhosis (severe scarring)...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01456468
Start Date
October 1 2011
End Date
December 1 2015
Last Update
July 14 2016
Active Locations (2)
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1
Yale University School of Medicine - 333 Cedar St - 1080 LMP
New Haven, Connecticut, United States, 06520
2
Mayo Clinic
Rochester, Minnesota, United States, 55905