At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 119 enrolled
Drug / intervention
HEPLISAV-B®drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
In Brief
A Phase 1 clinical trial evaluating HEPLISAV-B® for End Stage Renal Disease on Hemodialysis (Diagnosis). Completed, enrolled 119 participants across 20 sites.
Detailed Summary
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartApr 2019
First PostedMay 2019
Primary CompletionOct 2020
Study CompletionSep 2021
TodayJul 2026
First PostedMay 2, 2019
Enrollment StartApr 22, 2019
Primary CompletionOct 23, 2020
Study CompletionSep 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 7.2 years ago
Interventions
HEPLISAV-B®drug
HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine for adults 18 years of age and older, consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).