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NCT03934736 · ClinicalTrials.gov registry record · Phase 1
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
A Phase 1 study, sponsored by Dynavax Technologies Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 119
- Enrollment target
NCT03934736: Completed Phase 1 study, sponsored by Dynavax Technologies Corporation.
NCT03934736 is a Phase 1 study that has completed, run by Dynavax Technologies Corporation. The registered enrollment target is 119 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03934736, a Phase 1 study, has completed, sponsored by Dynavax Technologies Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 119 participants
- Enrollment target
Study Summary
This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
Primary Outcome
Proportion of participants with Medically-attended adverse events (MAEs), Serious Adverse Events (SAEs), and immune-mediated Adverse Events of Special Interest (AESIs). MAEs are Adverse events (AEs) for which a subject sought medical attention at a doctor's office, clinic or study site, or emergency room, or was hospitalized. SAEs are AEs that met the definition of Serious per FDA regulations.
Interventions
- DRUG HEPLISAV-B®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2019-04-22 |
| Est. Completion | 2021-09-15 |
| Phase | Phase 1 |
What the finished NCT03934736 record still lists
NCT03934736 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 1 intervention - of which HEPLISAV-B® is the first listed.
NCT03934736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03934736 about?
NCT03934736 is a clinical study titled "HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis". This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.
What is the current status of trial NCT03934736?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2019-04-22. Estimated completion is 2021-09-15.
What interventions are being tested in trial NCT03934736?
The interventions under investigation include: HEPLISAV-B® (DRUG).
Who is sponsoring clinical trial NCT03934736?
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 NCT03934736's enrollment target sits among peer trials
119 498th of 2000 higher than 1,502 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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