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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 is a Phase 1 study that has completed, run by Dynavax Technologies Corporation. The registered enrollment target is 42 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00426712
The ClinicalTrials.gov registry entry for NCT00426712 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dynavax Technologies Corporation, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hepatitis B Vaccine (Recombinant) is the first listed.
NCT00426712 reports 0 study locations.
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.
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