Protocol summary
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Study aim
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The effect of fenofibrate on the clinical outcome of parimary sclerosing cholangitis
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Design
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Clinical trial include 2 arm parallel (intervention group and control group), double blind, randomized in 3rd phase on 30 cases on primay sclerosing cholangitis
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Settings and conduct
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Selection of 30 patients with primary sclerosing cholangitis in terms of entry and exit indicators by a fixed person to whom the identity card details have not been transferred. Only patients' numbers and medication packages will be provided to them. It will be done by lottery. It will be available to the researcher in both blind and random directions
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Participants/Inclusion and exclusion criteria
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chronic cholestatic liver disease for 6 month, alkaline phosphatase serum level x1.5 ULN, imaging or histopathologic finding that confirmed disease
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Intervention groups
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Patients who have primary sclerosing cholangitis, Half of them as interventional group recieve tab fenofibrate 200mg daily and others as controller group recieve placebo capsule.
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Main outcome variables
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Pruritis, Alkalin Phosphatase serum level, Bilirubin serum level, mayo risk score
General information
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Reason for update
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control group, placebo intervention
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200427047225N1
Registration date:
2020-06-02, 1399/03/13
Registration timing:
registered_while_recruiting
Last update:
2022-01-28, 1400/11/08
Update count:
1
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Registration date
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2020-06-02, 1399/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-05-03, 1399/02/14
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Expected recruitment end date
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2020-11-04, 1399/08/14
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of Fenofibrate on the Clinical Outcome of primary Sclerosing Cholangitis
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Public title
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Fenofibrate in PSC
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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:
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
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-05-26, 1398/03/05
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Ethics committee reference number
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IR.SBMU.MSP.REC.1398.198
Health conditions studied
1
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Description of health condition studied
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primary sclerosing cholangitis disease
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ICD-10 code
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K74.1
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ICD-10 code description
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Hepatic sclerosis
Primary outcomes
1
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Description
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Serum Alkaline Phosphatase
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Timepoint
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Measurement of Serum Alkaline APhosphatase at base and after 6 month Therapy with Fenofibrate
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Method of measurement
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Chemistry Laboratory
Secondary outcomes
1
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Description
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Serum level of Billirubin
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Timepoint
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At base and after 6 month Therapy with Fenofibrate
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Method of measurement
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Chemistry Laboratory
2
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Description
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Pruritis
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Timepoint
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At base and after 6 month Therapy with Fenofibrate
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Method of measurement
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Questionary
3
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Description
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Mayo Risk Score
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Timepoint
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At base and after 6 month Therapy with Fenofibrate
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Method of measurement
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Mayo Risk Score system
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available