HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

End Stage Renal Disease on Dialysis (Diagnosis) Clinical Trial

Official title: An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

Status Active, not recruiting

Clinical Trial Summary

This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.

Clinical Trial Description

Eligible participants will receive single doses of HEPLISAV-B® at Weeks 0, 4, 8, and 16 and will be followed through Week 68 or end of study (EOS). The study is designed to evaluate the immunogenicity over a 20-week period and safety over a 68-week period. ;

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis (Diagnosis)
• Hepatitis B
• Kidney Diseases
• Kidney Failure, Chronic

• NCT number: NCT03934736
• Study type: Interventional
• Source: Dynavax Technologies Corporation
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 29, 2019
• Completion date: September 2021