this study aimed to evaluate the efficacy and safety of 40 mg/day atorvastatin on treatment of hepatitis B patients.
Design
single Blind, randomized clinical trial, with two controll and interventional groups. 40 patients with active hepatitis B were randomly divided into two groups. Random table and epi info software were used for random allocation of patients.
Settings and conduct
Patients with active hepatitis B referred to Shahid Beheshti Hospital Liver and Gastroenterology Clinic were randomly divided into control or intervention groups and treated.
Participants/Inclusion and exclusion criteria
Criteria for entering the study
Patients with chronic active hepatitis B are diagnosed with a doctor (gastroenterologist).
Patients with hepatitis B that are candidates for anti-viral therapy
Viral load greater than 100,000 copy/mL that is determined prior to treatment.
HBe Ag negative
No symptoms of cirrhosis and fibrosis
Exit criteria
Increased Hepatic Enzymes (ALT).
Severe renal failure
Use of immunosuppressive drugs
Acquired or congenital immune defects
Infections associated with autoimmune hepatitis, drugs, C and D and HIV
Taking medication with statins or tenofovir
History of taking statins or any other antiviral drug in the last six months
Age under 18 years
Alcoholic and non-alcoholic liver.
Intervention groups
The atorvastatin treating group recieve standard treatment for chronic HBV (300 mg Tenofovir twice a day) along with 40 mg/day atorvastatin for 12 months while, control group recieve standard regimen in addition to placebo once daily.
Main outcome variables
viral load and liver enzymes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110621006852N2
Registration date:2021-02-28, 1399/12/10
Registration timing:retrospective
Last update:2021-02-28, 1399/12/10
Update count:0
Registration date
2021-02-28, 1399/12/10
Registrant information
Name
Mohammad Reza Haeri
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4465 1176
Email address
haeri@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
2013-04-21, 1392/02/01
Actual recruitment end date
2014-04-21, 1393/02/01
Trial completion date
2014-04-21, 1393/02/01
Scientific title
The effect of Atorvastatin in combination to Tenofovir in the treatment of Hepatitis B
Public title
The effect of Atorvastatin in combination to Tenofovir in the treatment of Hepatitis B
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with active hepatitis B that are candidates for anti-viral therapy
Viral load greater than 100,000 per ml
patients with elevated ALT
Exclusion criteria:
All patients with severe kidney failure.
Patients who use suppressor drugs for immune system.
Patients with acquired or congenital immune deficiencies.
Patients who have had a history of taking statins or any other antiviral medicines in the last six months.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
43
Actual sample size reached:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participating patients did not know which group was preferred and in which group they are in. Only a specialist knew what group each person was. The analyzer also did not have an idea of which group was better or what type of medication was used, and analyzed only two sets of raw data.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical sciences
Street address
Alqadir Bolivard
City
Qom
Province
Ghoum
Postal code
3457731551
Approval date
2015-03-08, 1393/12/17
Ethics committee reference number
IR.MUQ.REC.1393.148
Health conditions studied
1
Description of health condition studied
Liver Disease
ICD-10 code
K71.6
ICD-10 code description
Toxic liver disease with hepatitis, not elsewhere classified
Primary outcomes
1
Description
viral load
Timepoint
At the beginning of the trial and then once every three months interval
Method of measurement
realtime PCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiver of tenofuir and atorvastatin. Tenofovir is the standard hepatitis B drug and is a reverse transcriptase nucleotide inhibitor. To maintain ethical standards, patients with hepatitis B are given Tenofovir manufactured by Hetero Healthcare 300 mg twice a day orally and 40 mg of the study drug, atorvastatin, as tablets made by Poursina factory. The duration of treatment with both drugs is 12 months. To detect the amount of virus, PCR tests are performed at times zero, first month, third month, sixth month, ninth month, and finally the twelfth month to measure the number of viruses in the blood and determine the effect of treatment on the number of viruses.
Category
Treatment - Drugs
2
Description
Control group: Tenofovir recipient alone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Yazdani
Street address
Shahid Beheshti Hospital, Imam Street, near Azadegan Square
City
Qom
Province
Ghoum
Postal code
34937157
Phone
+98 25 3291 7376
Email
haeri.mr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Ehsan Sharifipour
Street address
Shahid Beheshti Hospital, Imam Street, near Azadegan Square
City
Qom
Province
Ghoum
Postal code
34937157
Phone
+98 25 3291 7376
Email
haeri.mr@gmail.com
Grant name
Research council, Qom University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?