Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients

Summary

The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and are expected to eventually go on hemodialysis.

Timeline

Start

2006-01

Primary completion

2008-03

Completion

2008-03

Drugs

Indications