Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000246987
Ethics application status
Approved
Date submitted
26/02/2011
Date registered
7/03/2011
Date last updated
7/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Granulocyte Colony Stimulating Factor (GCSF) on Immune Response to Hepatitis B Vaccine in End-Stage Renal Disease (ESRD) Patients Undergoing Hemodialysis
Scientific title
The titer of Anti HBS Ab in hemodialysis patients receiving double dose HBV vaccine and simultaneous granulocyte-colony stimulating factor (G-CSF) is higher compared to hemodialysis patients receiving only double dose HBV vaccine
Secondary ID [1] 253608 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 261169 0
Condition category
Condition code
Renal and Urogenital 259323 259323 0 0
Other renal and urogenital disorders
Infection 259449 259449 0 0
Other infectious diseases

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 4 will be injected. GM-CSF will be administered after each injection of HBV vaccine.
Intervention code [1] 258111 0
Prevention
Intervention code [2] 264127 0
Treatment: Drugs
Comparator / control treatment
Intramuscular injection of double dose of HBV vaccine without GM-CSF
Control group
Active

Outcomes
Primary outcome [1] 262212 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] 262212 0
1 month after first dose of vaccine; and again 1 month after the last dose of vaccine ((the end of 5th month )
Secondary outcome [1] 273340 0
None
Timepoint [1] 273340 0
None

Eligibility
Key inclusion criteria
End stage renal disease (ESRD) patients on hemodialysis
Minimum age
No limit
Maximum age
No limit
Sex
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 and HCV positive patients

3. Those patients who has history of vaccination

4. Patients with chronic liver disease

5. Patients with congestive heart failure (class III and IV)

6. Patients with chronic lung disease

7. Patients with hypersensitivity to GM-CSF

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
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3198 0
Iran, Islamic Republic Of
State/province [1] 3198 0

Funding & Sponsors
Funding source category [1] 258566 0
University
Name [1] 258566 0
Shiraz University of medical science-
Country [1] 258566 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] 257707 0
University
Name [1] 257707 0
Shiraz University of medical science-
Address [1] 257707 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] 257707 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260551 0
Local ethical committe of Shiraz University of medical sciences
Ethics committee address [1] 260551 0
Ethics committee country [1] 260551 0
Date submitted for ethics approval [1] 260551 0
Approval date [1] 260551 0
Ethics approval number [1] 260551 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32216 0
Address 32216 0
Country 32216 0
Phone 32216 0
Fax 32216 0
Email 32216 0
Contact person for public queries
Name 15463 0
Ahad Eshraghian
Address 15463 0
Internal medicine department, Namazi Hospital, Shiraz, Fars, Iran
P.C 71345-1744

Tel: 00989177311442
Country 15463 0
Iran, Islamic Republic Of
Phone 15463 0
00989177311442
Fax 15463 0
Email 15463 0
[email protected]
Contact person for scientific queries
Name 6391 0
Kamran B Lankarani
Address 6391 0
Health policy research center, 5th floor, Shiraz University of medical science, Zand Ave, Shiraz, Fars, Iran.
P.C: 71345-1877
Country 6391 0
Iran, Islamic Republic Of
Phone 6391 0
0098 711 230 9615
Fax 6391 0
Email 6391 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.