Status:
COMPLETED
Does Extra-High Dose Hepatitis B Vaccination Confer Longer Serological Protection in Peritoneal Dialysis Patients?
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Peritoneal Dialysis
Renal Disease, End-Stage
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Hepatitis B virus causes inflammation of the liver which is detrimental to the end-stage renal disease patients on dialysis. Hepatitis B vaccine is recommended for this high-risk population although t...
Detailed Description
The objective of the present randomized study is to evaluate the optimum strategy of recombinant hepatitis B vaccination in the maintenance of protective anti-HBs antibody among end-stage renal diseas...
Eligibility Criteria
Inclusion
- Age above 18 years
- End-stage renal disease and on maintenance peritoneal dialysis
- Serologically negative for hepatitis B surface antigen (HBsAg) and antibody to hepatitis core antigen (anti-HBc)
- No history of receiving hepatitis B vaccination
- Willingness to give written informed consent and willingness to participate in and comply with the study protocol
Exclusion
- Expected survival less than 6 months
- Those who refused vaccination
- Active malignancy
- Alcoholic liver disease
- Chronic hepatitis C and/or human immunodeficiency virus (HIV) infection
- Receiving immunosuppressive medications
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00125775
Start Date
May 1 2005
End Date
December 1 2009
Last Update
January 7 2010
Active Locations (1)
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1
Prince of Wales Hospital
New Territories, New Territories, Hong Kong, SAR