At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 521 enrolled
Drug / intervention
HEPLISAV-B +2 morebiological
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 Observer-Blinded, Randomized Study Comparing the Safety and Immunogenicity of HEPLISAV-B® to Licensed Vaccine (Engerix-B®) Among Adults(18 to 75 Years of Age) With Chronic Kidney Disease (CKD)
In Brief
A Phase 3 clinical trial evaluating HEPLISAV-B, Engerix-B, and 1 other intervention for Chronic Kidney Disease. Completed, enrolled 521 participants across 1 site.
Detailed Summary
The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedSep 2009
Primary CompletionJan 2012
TodayJul 2026
First PostedSep 28, 2009
Enrollment StartSep 1, 2009
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.8 years ago
Interventions
HEPLISAV-Bbiological
Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24
Engerix-Bbiological
Intramuscular (IM) injections at Weeks 0, 4, 8, and 24
Placeboother
Placebo(saline) intramuscular (IM) injection at Week 8