Fenofibrate in PSC
- Conditions
- primary sclerosing cholangitis disease.Hepatic sclerosisK74.1
- Registration Number
- IRCT20200427047225N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
chronic cholestatic liver disease for atleast 6 month
alkaline phosphatase serum level atleast 1.5x upper limit normal
multi focal dilation and stricture in intra/extra hepatic billiary ducts on MRCP or liver biopsy confirmed PSC (fibrosing cholangitis, ductopenia, peei portal inflammation or biliary fibrosis)
concurrent advanced malignancy or severe cardiopulmonary disease with less than 2 years survival
inlammatory intestinal diseasethat need medical therapy during 3 month from begining (except miantenance therapy with 5-ASA)
candidate for liver transplant and survival less than 80% in 2 years according to MAYO risk score
portal hypertension complicatin such as variceal bleeding ascitis liver encephalopathy
pregnancy or breast feeding
age under 18 years or above 75 years
other liver disease diagonosis sucg as chronic alcoholic livera disease, B or C hepatitis, auto immune hepatitis, primary biliary cirrosis, hemochromatosis, wilson disease, congenital biliary disease or cholangiocarcinoma
previous biliary stone or ductal manipulation, cholecycstectomy or other biliary drainage before PSC confirmed
ascending biliary cholangitis need more than twice a years admission
patient who di not allow
fenofibrate allergy or intolerance or side effects
concurrent use of local or systemic anti-itch agents such as anti histamins
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum Alkaline Phosphatase. Timepoint: Measurement of Serum Alkaline APhosphatase at base and after 6 month Therapy with Fenofibrate. Method of measurement: Chemistry Laboratory.
- Secondary Outcome Measures
Name Time Method Serum level of Billirubin. Timepoint: At base and after 6 month Therapy with Fenofibrate. Method of measurement: Chemistry Laboratory.;Pruritis. Timepoint: At base and after 6 month Therapy with Fenofibrate. Method of measurement: Questionary.;Mayo Risk Score. Timepoint: At base and after 6 month Therapy with Fenofibrate. Method of measurement: Mayo Risk Score system.