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IRCT20200427047225N1 IRCT 2020-06-02 Shahid Beheshti University of Medical Sciences Fenofibrate in PSC The effect of Fenofibrate on the Clinical Outcome of primary Sclerosing Cholangitis 2020-05-03 anticipated 30 Complete https://irct.ir/trial/47649 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial we assumed minimum number of cases is 30. for random selection, patients were numbered according to entrance respectively. RV.uniform function in SPSS was executed, if the output was more than 0.5 patient will categorize as group 1 (intervention), otherwise in group 2 (control). if number of each group reach 15 cases, no more cases will be added to that group, Blinding description: The selection of patients in terms of inclusion and exclusion criteria in a targeted manner and by a fixed person to whom th eidentify card details of individuals have not been transferred and only the numbers of patients and drug package will be provided to them, will be done by lottery and given to the researcher. 3 primary sclerosing cholangitis disease. Intervention 1: Intervention group: Fifteen patients aged 18 to 75 years with primary sclerosing cholangitis are initially assessed in terms of liver enzyme levels, pruritus, and Mayo risk score. Patients then take 200 mg of phenofibrate tablets daily for 6 months in addition to the underlying disease medications (according to the study entry and exit indices). At the end of the sixth month, patients will be re-examined for liver enzymes, itching, and Mayo risk scores. Data analysis will be performed using SPSS version 24 software. p> 0.05 is considered a significant level. Intervention 2: Control group: Control group: 15 patients aged 18 to 75 years with primary sclerosing cholangitis are initially examined for liver enzyme levels, pruritus, and Mayo score. Patients receive background medications and placebo (a capsul same as fenofibrate) for 6 months. At the end of the sixth month, patients will be re-examined for liver enzymes, itching, and Mayo score, and compared with the intervention group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mozhde Mosala
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Tehran Iran (Islamic Republic of) 1469617491 +98 21 4443 8262 mohd109@gmail.com Shahid Beheshti University of Medical Sciences scientific Mozhde Mosala
No 35, east Golestan ave, Ashrafi Esfahani hw, south Pounak
Tehran Iran (Islamic Republic of) 1469617491 +98 21 4443 8262 mohd109@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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) 18 years 75 years Both 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 K74.1 Hepatic sclerosis Treatment - Drugs N/A Intervention group: Fifteen patients aged 18 to 75 years with primary sclerosing cholangitis are initially assessed in terms of liver enzyme levels, pruritus, and Mayo risk score. Patients then take 200 mg of phenofibrate tablets daily for 6 months in addition to the underlying disease medications (according to the study entry and exit indices). At the end of the sixth month, patients will be re-examined for liver enzymes, itching, and Mayo risk scores. Data analysis will be performed using SPSS version 24 software. p> 0.05 is considered a significant level. Control group: Control group: 15 patients aged 18 to 75 years with primary sclerosing cholangitis are initially examined for liver enzyme levels, pruritus, and Mayo score. Patients receive background medications and placebo (a capsul same as fenofibrate) for 6 months. At the end of the sixth month, patients will be re-examined for liver enzymes, itching, and Mayo score, and compared with the intervention group. Serum Alkaline Phosphatase. Timepoint: Measurement of Serum Alkaline APhosphatase at base and after 6 month Therapy with Fenofibrate. Method of measurement: Chemistry Laboratory. 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. Shahid Beheshti University of Medical Sciences Approved 2019-05-26 Ethics committee of Shahid Beheshti University of Medical sciences School of Medicine, koodakyar street, Daneshjoo blvd, Velenjak, Shahid Chamran Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)