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Protocol summary
Patients who have primary sclerosing cholangitis, Half of them as interventional group recieve tab fenofibrate 200mg daily and others as controller group recieve no fenofibrate.
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.
Patients who have primary sclerosing cholangitis, Half of them as interventional group recieve tab fenofibrate 200mg daily and others as controller group recieve no fenofibrateplacebo capsule.
بیماران مبتلا به بیماری کلانژیت اسکلروزان اولیه که نیمی از بیماران تحت درمان با قرص فنوفیبرات 200 میلیگرمی روزانه قرار میگیرند و نیمی از بیماران به عنوان گروه کنترل دارو دریافت نمیکنند.
بیماران مبتلا به بیماری کلانژیت اسکلروزان اولیه که نیمی از بیماران تحت درمان با قرص فنوفیبرات 200 میلیگرمی روزانه قرار میگیرند و نیمی از بیماران به عنوان گروه کنترل دارونما دریافت میکنند.
بیماران مبتلا به بیماری کلانژیت اسکلروزان اولیه که نیمی از بیماران تحت درمان با قرص فنوفیبرات 200 میلیگرمی روزانه قرار میگیرند و نیمی از بیماران به عنوان گروه کنترل دارودارونما دریافت نمیکنندمیکنند.
General information
Not used
Used
nusedused
empty
control group, placebo intervention
control group, placebo intervention
empty
اصلاح گروه کنترل و دریافت دارو نما
اصلاح گروه کنترل و دریافت دارو نما
Secondary outcomes
#1
امتیازدهی خطر متیو
امتیازدهی خطر مایو
امتیازدهی خطر متیومایو
Intervention groups
#1
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 only background medications for 6 months and no intervention. 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.
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.
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 only background medications and placebo (a capsul same as fenofibrate) for 6 months and no intervention. 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.
گروه کنترل: 15بیمار 18 تا 75 ساله مبتلا به کلانژیت اسکلروزان اولیه در ابتدا از نظر سطح آنزیم های کبدی، خارش و امتیاز Mayo بررسی میشوند. بیماران در طی 6 ماه فقط داروهای بیماری زمینه ای را دریافت میکنند و هیچ نوع مداخله ای در آنها انجام نمیشود. در پایان ماه ششم مجددا بیماران از نظر آنزیم های کبدی، خارش و امتیاز Mayo بررسی خواهند شد و در قیاس با گروه مداخله قرار خواهند گرفت.
گروه کنترل: 15بیمار 18 تا 75 ساله مبتلا به کلانژیت اسکلروزان اولیه در ابتدا از نظر سطح آنزیم های کبدی، خارش و امتیاز Mayo بررسی میشوند. بیماران در طی 6 ماه داروهای بیماری زمینه ای و کپسول دارونما مشابه هم سایز و هم رنگ با کپسول فنوفیبرات را دریافت میکنند. در پایان ماه ششم مجددا بیماران از نظر آنزیم های کبدی، خارش و امتیاز Mayo بررسی خواهند شد و در قیاس با گروه مداخله قرار خواهند گرفت.
گروه کنترل: 15بیمار 18 تا 75 ساله مبتلا به کلانژیت اسکلروزان اولیه در ابتدا از نظر سطح آنزیم های کبدی، خارش و امتیاز Mayo بررسی میشوند. بیماران در طی 6 ماه فقط داروهای بیماری زمینه ای و کپسول دارونما مشابه هم سایز و هم رنگ با کپسول فنوفیبرات را دریافت میکنند و هیچ نوع مداخله ای در آنها انجام نمیشود. در پایان ماه ششم مجددا بیماران از نظر آنزیم های کبدی، خارش و امتیاز Mayo بررسی خواهند شد و در قیاس با گروه مداخله قرار خواهند گرفت.
Recruitment centers
#1
Name of recruitment center - English: پژوهشکده بیماری های گوارش و کبد بیمارستان طالقانی
Name of recruitment center - Persian: institute of gastroenterology and liver disease
Full name of responsible person - English: دکتر بهزاد حاتمی
Full name of responsible person - Persian: dr behzad hatami
Street address - English: 50m after taleghani hospital, arabi street, yaman street, chamran highway
Street address - Persian: بزرگراه چمران، خیابان یمن، خیابان اعرابی، 50متر جلوتر از بیمارستان طالقانی، پژوهشکده بیماریهای گوارش و کبد
City - English: تهران
City - Persian: tehran
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: +98 21 2243 2526
Fax:
Email: mohd109@gmail.com
Web page address: http://rigld.sbmu.ac.ir
Name of recruitment center - English: institute of gastroenterology and liver disease
Name of recruitment center - Persian: پژوهشکده بیماریهای گوارش و کبد بیمارستان طالقانی
Full name of responsible person - English: Dr. Behzad Hatami
Full name of responsible person - Persian: دکتر بهزاد حاتمی
Street address - English: 50m after Taleghani Hospital, Arabi street, Yaman street, Chamran Highway
Street address - Persian: بزرگراه چمران، خیابان یمن، خیابان اعرابی، 50متر جلوتر از بیمارستان طالقانی، پژوهشکده بیماریهای گوارش و کبد
City - English: تهران
City - Persian: tehran
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985717413
Phone: +98 21 2243 2526
Fax:
Email: mohd109@gmail.com
Web page address: http://rigld.sbmu.ac.ir
Name of recruitment center - English: پژوهشکده بیماری های گوارش و کبد بیمارستان طالقانیinstitute of gastroenterology and liver disease Name of recruitment center - Persian: institute of gastroenterology and liver diseaseپژوهشکده بیماریهای گوارش و کبد بیمارستان طالقانی Full name of responsible person - English: دکتر بهزاد حاتمیDr. Behzad Hatami Full name of responsible person - Persian: dr behzad hatamiدکتر بهزاد حاتمی Street address - English: 50m after taleghani hospitalTaleghani Hospital, arabiArabi street, yamanYaman street, chamran highwayChamran Highway Street address - Persian: بزرگراه چمران، خیابان یمن، خیابان اعرابی، 50متر جلوتر از بیمارستان طالقانی، پژوهشکده بیماریهای گوارش و کبد City - English: تهران City - Persian: tehran Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985717413 Phone: +98 21 2243 2526 Fax: Email: mohd109@gmail.com Web page address: http://rigld.sbmu.ac.ir
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: معاون تقیقات و فناوری دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - Persian: vice president research and innovation
Street address - English: flour 5th, setad 2 building, shahid beheshtin university of medical science, arabi street, yaman street, chamran hifhway
Street address - Persian: بزرگراه چمران، خیابان یمن، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی، ساختمان ستاد 2، طبقه 5
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1983963113
Phone: +98 21 2243 9781
Fax: +98 21 2243 9981
Email: Mpajouhesh@sbmu.ac.ir
Web page address: https://retech.sbmu.ac.ir
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice President Research and Innovation
Full name of responsible person - Persian: معاون تحقیقات و فناوری دانشگاه علوم پزشکی شهید بهشتی
Street address - English: Floor 5th, Setad 2 uilding, Shahid Beheshtin University of Medical Science, Arabi street, Yaman street, Chamran Highway
Street address - Persian: بزرگراه چمران، خیابان یمن، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی، ساختمان ستاد 2، طبقه 5
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1983963113
Phone: +98 21 2243 9781
Fax: +98 21 2243 9981
Email: Mpajouhesh@sbmu.ac.ir
Web page address: https://retech.sbmu.ac.ir
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: معاون تقیقات و فناوری دانشگاه علوم پزشکی شهید بهشتیVice President Research and Innovation Full name of responsible person - Persian: vice president research and innovationمعاون تحقیقات و فناوری دانشگاه علوم پزشکی شهید بهشتی Street address - English: flourFloor 5th, setadSetad 2 buildinguilding, shahid beheshtin universityShahid Beheshtin University of medical scienceMedical Science, arabiArabi street, yamanYaman street, chamran hifhwayChamran Highway Street address - Persian: بزرگراه چمران، خیابان یمن، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی، ساختمان ستاد 2، طبقه 5 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1983963113 Phone: +98 21 2243 9781 Fax: +98 21 2243 9981 Email: Mpajouhesh@sbmu.ac.ir Web page address: https://retech.sbmu.ac.ir
Protocol summary
Study aim
The effect of fenofibrate on the clinical outcome of parimary sclerosing cholangitis
Design
Clinical trial include 2 arm parallel (intervention group and control group), double blind, randomized in 3rd phase on 30 cases on primay sclerosing cholangitis
Settings and conduct
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
Participants/Inclusion and exclusion criteria
chronic cholestatic liver disease for 6 month, alkaline phosphatase serum level x1.5 ULN, imaging or histopathologic finding that confirmed disease
Intervention groups
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.
The effect of Fenofibrate on the Clinical Outcome of primary Sclerosing Cholangitis
Public title
Fenofibrate in PSC
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical sciences
Street address
School of Medicine, koodakyar street, Daneshjoo blvd, Velenjak, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-05-26, 1398/03/05
Ethics committee reference number
IR.SBMU.MSP.REC.1398.198
Health conditions studied
1
Description of health condition studied
primary sclerosing cholangitis disease
ICD-10 code
K74.1
ICD-10 code description
Hepatic sclerosis
Primary outcomes
1
Description
Serum Alkaline Phosphatase
Timepoint
Measurement of Serum Alkaline APhosphatase at base and after 6 month Therapy with Fenofibrate
Method of measurement
Chemistry Laboratory
Secondary outcomes
1
Description
Serum level of Billirubin
Timepoint
At base and after 6 month Therapy with Fenofibrate
Method of measurement
Chemistry Laboratory
2
Description
Pruritis
Timepoint
At base and after 6 month Therapy with Fenofibrate
Method of measurement
Questionary
3
Description
Mayo Risk Score
Timepoint
At base and after 6 month Therapy with Fenofibrate
Method of measurement
Mayo Risk Score system
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
institute of gastroenterology and liver disease
Full name of responsible person
Dr. Behzad Hatami
Street address
50m after Taleghani Hospital, Arabi street, Yaman street, Chamran Highway
City
تهران
Province
Tehran
Postal code
1985717413
Phone
+98 21 2243 2526
Email
mohd109@gmail.com
Web page address
http://rigld.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice President Research and Innovation
Street address
Floor 5th, Setad 2 uilding, Shahid Beheshtin University of Medical Science, Arabi street, Yaman street, Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Web page address
https://retech.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mozhde Mosala
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No 35, east Golestan ave, Ashrafi Esfahani hw, south Pounak
City
Tehran
Province
Tehran
Postal code
1469617491
Phone
+98 21 4443 8262
Fax
Email
mohd109@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mozhde Mosala
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No 35, east Golestan ave, Ashrafi Esfahani hw, south Pounak
City
Tehran
Province
Tehran
Postal code
1469617491
Phone
+98 21 4443 8262
Fax
Email
mohd109@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mozhde Mosala
Position
Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No 35, east Golestan ave, Ashrafi Esfahani hw, south Pounak
City
Tehran
Province
Tehran
Postal code
1469617491
Phone
+98 21 4443 8262
Fax
Email
mohd109@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available