CompletedPhase 1

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

United States119 participantsStarted 2019-04-22

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Systemic corticosteroids (more than 3 consecutive days) or other immunomodulatory or immune suppressive medication with the exception of inhaled steroids
✕. Any live virus vaccine
✕. Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
✕. Any other investigational medicinal agent
✕. Blood products or immunoglobulin

What they're measuring

Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special Interest

Timeframe: Week 0 (Visit 1) until Week 68 or early termination

Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune Response

Timeframe: Week 20

Trial details

NCT IDNCT03934736

SponsorDynavax Technologies Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-23

Results submitted2022-06-08

View on ClinicalTrials.gov More End Stage Renal Disease on Hemodialysis (Diagnosis) trials