Dynavax Reports Interim Analysis of Ongoing Clinical Trial Evaluating HEPLISAV-B in Patients Undergoing Hemodialysis
Retrieved on:
Tuesday, April 28, 2020
Interim analysis of safety data in 70 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) who are initiating or undergoing hemodialysis, showed HEPLISAV-B was well tolerated with a seroprotection rate of 86.4% in 44 patients.
Key Points:
- Interim analysis of safety data in 70 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) who are initiating or undergoing hemodialysis, showed HEPLISAV-B was well tolerated with a seroprotection rate of 86.4% in 44 patients.
- We are pleased with these interim results from the hemodialysis trial which reinforce the existing clinical data set regarding the safety and rates of protection provided by HEPLISAV-B, commented Robert Janssen , MD, Chief Medical Officer at Dynavax.
- The study is designed to evaluate HEPLISAV-Bs immunogenicity at study week 20 and safety over the 68-week study duration.
- Safety and effectiveness of a 4-dose regimen of HEPLISAV-B have not been established in adults on hemodialysis.