The Effect of Granulocyte Colony Stimulating Factor (GCSF) on Immune Response to Hepatitis B Vaccine in End-Stage Renal Disease (ESRD) Patients Undergoing Hemodialysis

Phase 1

• Conditions: Immunity against hepatitis B virus; Renal and Urogenital - Other renal and urogenital disorders; Infection - Other infectious diseases

• Registration Number: ACTRN12611000246987
• Lead Sponsor: Kamran Bagheri Lankarani

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

End stage renal disease (ESRD) patients on hemodialysis

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
antibody against hepatitis B surface antigen (anti-HBS antibody) with a titer of 10IU/L or more after blood analysis,<br>This was measured by blood sample analysis.<br>The titer of anti HBS antibody in blood samples will be examined[1 month after first dose of vaccine; and again 1 month after the last dose of vaccine ((the end of 5th month )]

Secondary Outcome Measures

Name	Time	Method
one[None]