Assessment of effect of granulocyte colony stimulating factor (G-CSF) on immune response to vaccination against hepatitis B in patients awaiting liver transplantation.

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?

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001180909

Enrollment

Registered

2011-11-14

Start date

2012-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will be conducted to evaluate the effect of GM-CSF in titer of HBV antibody in patients with cirrhosis

Interventions

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.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

20 Years to 65 Years

Healthy volunteers

Inclusion criteria

Cirrhotic patients between 20 and 65 years on waiting list for liver transplantation

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.....

Outcome results