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HEPLISAV-B in Adults With End-Stage Renal Disease Undergoing Hemodialysis
NCT03934736Phase 1Completed
- Sponsor
- Dynavax Technologies
- Start
- Apr 2019
- Primary completion
- Oct 2020
- Modality
- Split/Subunit Vaccines, Recombinant Protein Vaccines
- Countries
- 1
01
Overview
Phase 1, open-label, single-arm trial of Heplisav-B in hepatitis B (HBV), sponsored by Dynavax Technologies. Primary endpoints: Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest and Seroprotection Rate (SPR) at Week 20. Started Apr 2019; status: completed.
02
Drugs
Heplisav-B
03
Conditions
hepatitis B (HBV)
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