Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-24 @ 5:46 PM
NCT ID:
NCT01456468
Eligibility Criteria:
Inclusion Criteria:
* 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:
1. Cholangitis within the past 12 months.
2. Presence or progression of biliary abnormalities on MRI/MRC.
3. Elevated liver tests (alkaline phosphatase, bilirubin, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\]).
* Age between 18 and 80.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01456468
Study Brief:
Protocol Section:
NCT01456468