primary sclerosing cholangitis disease. Hepatic sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Alkaline Phosphatase. Timepoint: Measurement of Serum Alkaline APhosphatase at base and after 6 month Therapy with Fenofibrate. Method of measurement: Chemistry Laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Shahid Beheshti University of Medical Sciences