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HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

NCT03934736 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2024-08-09

Study results available
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Summary

This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.

Conditions

  • End Stage Renal Disease on Hemodialysis (Diagnosis)

Interventions

DRUG

HEPLISAV-B®

HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine for adults 18 years of age and older, consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Robert Janssen, MD · Dynavax Technologies Corporation

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2020-10-23
Completion
2021-09-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03934736 on ClinicalTrials.gov