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Investigation the effect of adding Atorvastatin to routine Tenofovir treatment on severity of liver fibrosis and liver function among patients with chronic hepatitis B

Protocol summary

Summary
The main purpose: Effect of adding Atorvastatin to Tenofovir on severity of liver fibrosis and liver function for treatment of patients with chronic hepatitis B. Design: Double blind randomized controlled trial Inclusion criteria: Patients between 18 and 75 years old with chronic hepatitis B for more than 6 months and dysfunction in liver function, serum LDL more than 90 mg/dl Exclusion criteria: Patients with hepatitis B less than 6 months, Inactive carriers of hepatitis B, Patients with no fibrosis and cirrhosis, Patients with decompensated cirrhosis, Patients with chronic liver disease such as willson and hemochromatosis, Patients with hepatic cell carcinoma, Patients with other malignancies, Patients with co-infection and superinfection of HIV ,HCV or HDV, Patients that were treated with Atorvastatin, Pregnant and lactating women, Increasing of liver enzymes 2 times of normal range after 1 months of treatment. Sample size: 80 Patients Intervention: adding Atorvastatin to routine treatment Duration of intervention: 6 months Outcomes: liver function and liver fibrosis

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017010631252N3
Registration date: 2017-03-02, 1395/12/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-02, 1395/12/12
Registrant information
Name
Ahmad Hormati
Name of organization / entity
Qom university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2053
Email address
hormatia@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of adding Atorvastatin to routine Tenofovir treatment on severity of liver fibrosis and liver function among patients with chronic hepatitis B
Public title
Effect of Atorvastatin on liver function in patients with chronic hepatitis B
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 18 and 75 years old with chronic hepatitis B for more than 6 months and dysfunction in liver function, serum LDL more than 90 mg/dl Exclusion criteria: Patients with hepatitis B less than 6 months, Inactive carriers of hepatitis B, Patients with no fibrosis and cirrhosis, Patients with decompensated cirrhosis, Patients with chronic liver disease such as willson and hemochromatosis, Patients with hepatic cell carcinoma, Patients with other malignancies, Patients with co-infection and superinfection of HIV ,HCV or HDV, Patients that were treated with Atorvastatin, Pregnant and lactating women, Increasing of liver enzymes 2 times of normal range after 1 months of treatment.
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Oom University of Medical Sciences
Street address
Oom University of Medical Sciences, Saheli street, Qom
City
Qom
Postal code
3713649373
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.MUQ.REC.1395.133

Health conditions studied

1

Description of health condition studied
chronic hepatitis
ICD-10 code
K73.0
ICD-10 code description
Chronic persistent hepatitis

Primary outcomes

1

Description
Sevirity of fibrosis
Timepoint
Six months after begining intervention
Method of measurement
kpa with fibroscan

2

Description
Liver function
Timepoint
Six months after intervention
Method of measurement
Child score

Secondary outcomes

1

Description
Liver enzymes levels
Timepoint
Six month after begining of intervention
Method of measurement
Blood levels with IU/ml

Intervention groups

1

Description
In intervention group, Atorvastatin tablet, 20 mg, oral, once daily, for six months
Category
Treatment - Drugs

2

Description
In control group, Atorvastatin placebo, oral, once daily, for six months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology and Hepatology Research Center, Qom University of Medical Sciences
Full name of responsible person
Dr Mahdi Jahangiry
Street address
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Fahime Aliabadi
Street address
Namber 83, Alley 4, Alley 1.1, Safashahr Street
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mahdi Jahangiry
Position
medical doctor, resident of internal medicine
Other areas of specialty/work
Street address
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv
City
Qom
Postal code
3719964797
Phone
+98 25 3612 2053
Fax
+98 25 3612 2053
Email
mahdijahangiry@yahoo.com; hormatia@yahoo.com
Web page address
ddrc.muq.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Ahmad Hormati
Position
Assistant Professor of adults Gastroenterology and hepatology
Other areas of specialty/work
Street address
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv
City
Qom
Postal code
3719964797
Phone
+98 25 3612 2053
Fax
+98 25 3612 2053
Email
hormatia@yahoo.com; hormatia@muq.ac.ir
Web page address
ddrc.muq.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Ahmad Hormati
Position
Assistant Professor of adults Gastroenterology and hepatology
Other areas of specialty/work
Street address
Gastroenterology and Hepatology Disease Research Center, Endoscopy Unit, Shahid Beheshti Hospital Qom, Shahid Beheshti Blv
City
Qom
Postal code
3719964797
Phone
+98 25 3612 2053
Fax
+98 25 3612 2053
Email
hormatia@yahoo.com; hormatia@muq.ac.ir
Web page address
ddrc.muq.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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