clinical trial · NCT03934736
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
End Stage Renal Disease on Hemodialysis (Diagnosis)HEPLISAV-B®
brief summary
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
started
Apr 22, 2019
primary completion
Oct 23, 2020
completion
Sep 15, 2021
last updated
Aug 9, 2024
detailed 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.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol