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Trial registered on ANZCTR


Registration number
ACTRN12611001180909
Ethics application status
Approved
Date submitted
23/10/2011
Date registered
14/11/2011
Date last updated
14/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of effect of granulocyte colony stimulating factor (G-CSF) on immune response to vaccination against hepatitis B in patients awaiting liver transplantation.
Scientific title
Is the titer of Anti HBS Ab in cirrhotic patients receiving double dose HBV vaccine and simultaneous granulocyte-colony stimulating factor (G-CSF) higher compared to cirrhotic patients receiving only double dose HBV vaccine?
Secondary ID [1] 273255 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunity against hepatitis B virus 279020 0
cirrhosis 279152 0
Condition category
Condition code
Oral and Gastrointestinal 279205 279205 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 279341 279341 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramuscular injection of double dose of HBV vaccine (40 micro gr) and simultaneous injection of Granolocyte monocyte colony stimulating factor (GM-CSF) (300 micro gr). 3 doses of HBV vaccine at months 0,1 and 2 will be injected. GM-CSF will be administered after each injection of HBV vaccine.
Intervention code [1] 269598 0
Prevention
Comparator / control treatment
Intramuscular injection of double dose of HBV vaccine without GM-CSF
Control group
Active

Outcomes
Primary outcome [1] 279840 0
antibody against hepatitis B surface antigen (anti-HBS antibody) with a titer of 10IU/L or more after blood analysis, This was measured by blood sample analysis. The titer of anti HBS antibody in blood samples will be examined
Timepoint [1] 279840 0
1 month after first dose of vaccine; and again 1 month after the last dose of vaccine ((the end of 3rd month )
Secondary outcome [1] 294552 0
None
Timepoint [1] 294552 0
None

Eligibility
Key inclusion criteria
Cirrhotic patients between 20 and 65 years on waiting list for liver transplantation
Minimum age
20 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous history of viral hepatitis (HBS POSITIVE OR anti HBC Ab positive 2. HIV patients 3. Those patients who has history of vaccination 4. Patients with hepatocellular carcinoma 5. Patients with congestive heart failure (class III and IV) 6. Patients with serum creatinine >1.5 mg/dL 7. Patients with hypersensitivity to GM-CSF
8. Using immunosuppresive agents like azathioporine, tacrolimus.....

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3922 0
Iran, Islamic Republic Of
State/province [1] 3922 0

Funding & Sponsors
Funding source category [1] 284082 0
University
Name [1] 284082 0
Shiraz University of medical science-
Address [1] 284082 0
7th floor, Deputy of research and technology, Shiraz University of medical sciences, Zand Ave, Shiraz, Fars province, Iran, P.C:71345-1845
Country [1] 284082 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Kamran Bagheri Lankarani
Address
Health policy research center,5th floor, Shiraz medical school, Zand Ave, Shiraz, Fars province, Iran. P.C: 71345-1877
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 269049 0
University
Name [1] 269049 0
Shiraz University of medical science-
Address [1] 269049 0
7th floor, Deputy of research and technology, Shiraz University of medical sciences, Zand Ave, Shiraz, Fars province, Iran, P.C:71345-1845
Country [1] 269049 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272040 0
Local ethical committe of Shiraz University of medical sciences
Ethics committee address [1] 272040 0
Ethics committee country [1] 272040 0
Date submitted for ethics approval [1] 272040 0
Approval date [1] 272040 0
Ethics approval number [1] 272040 0

Summary
Brief summary
This study will be conducted to evaluate the effect of GM-CSF in titer of HBV antibody in patients with cirrhosis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33298 0
Address 33298 0
Country 33298 0
Phone 33298 0
Fax 33298 0
Email 33298 0
Contact person for public queries
Name 16545 0
Ahad Eshraghian
Address 16545 0
Internal medicine department, Namazi Hospital, Shiraz, Fars, Iran P.C 71345-1744
Country 16545 0
Iran, Islamic Republic Of
Phone 16545 0
+98 9177311442
Fax 16545 0
Email 16545 0
eshraghiana@yahoo.com
Contact person for scientific queries
Name 7473 0
Kamran B Lankarani
Address 7473 0
Health policy research center, 5th floor, Shiraz University of medical science, Zand Ave, Shiraz, Fars, Iran. P.C: 71345-1877
Country 7473 0
Iran, Islamic Republic Of
Phone 7473 0
+ 98 711 2309615
Fax 7473 0
Email 7473 0
lankaran@sums.ac.ir

No information has been provided regarding IPD availability
Summary results
No Results