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NCT00426712 · ClinicalTrials.gov registry record · Phase 1
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients
A Phase 1 study, sponsored by Dynavax Technologies Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT00426712: Completed Phase 1 study, sponsored by Dynavax Technologies Corporation.
NCT00426712 is a Phase 1 study that has completed, run by Dynavax Technologies Corporation. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00426712, a Phase 1 study, has completed, sponsored by Dynavax Technologies Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and are expected to eventually go on hemodialysis.
Interventions
- BIOLOGICAL Hepatitis B Vaccine (Recombinant)
- BIOLOGICAL 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2006-01 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
What the finished NCT00426712 record still lists
NCT00426712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Hepatitis B Vaccine (Recombinant) is the first listed.
NCT00426712 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00426712 about?
NCT00426712 is a clinical study titled "Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure Patients". The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and are expected to eventu...
What is the current status of trial NCT00426712?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2006-01. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00426712?
The interventions under investigation include: Hepatitis B Vaccine (Recombinant) (BIOLOGICAL), 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen (BIOLOGICAL).
Who is sponsoring clinical trial NCT00426712?
This trial is sponsored by Dynavax Technologies Corporation, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00426712's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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