18 and older, any sex, with End Stage Renal Disease on Hemodialysis (Diagnosis). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Subjects Reporting Clinically Significant Adverse Events - Medically-attended Adverse Events, Serious Adverse Events, and Immune-mediated Adverse Events of Special InterestPrimary· Week 0 (Visit 1) until Week 68 or early termination
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.
New-onset Immune-mediated Adverse Events
Group
Value
95% CI
HEPLISAV-B
0.8
Medically-attended Adverse Events
Group
Value
95% CI
HEPLISAV-B
66.4
Serious Adverse Events
Group
Value
95% CI
HEPLISAV-B
48.7
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune ResponsePrimary· Week 20
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B
Group
Value
95% CI
HEPLISAV-B®
89.3
80.1 – 95.3
Percentage of Subjects With Anti-HBs Concentration ≥100 mIU/mLSecondary· Weeks 4, 8, 16, 20
Percentage of subjects with anti-HBs concentration ≥100 mIU/mL.
Serum Anti-HBsAg Geometric Mean Concentration (GMC).
Week 4
Group
Value
95% CI
HEPLISAV-B
4.4
3.0 – 6.5
Week 8
Group
Value
95% CI
HEPLISAV-B
33.5
17.5 – 64.3
Week 16
Group
Value
95% CI
HEPLISAV-B
155.3
81.5 – 296.2
Week 20
Group
Value
95% CI
HEPLISAV-B
1061.8
547.2 – 2060.2
Seroprotection Rate (SPR) = Percentage of Participants Who Have a Seroprotective Immune ResponseSecondary· Weeks 4, 8, 16, 20
SPR is the percentage of participants who have a seroprotective immune response (antibody level to anti-HBsAg greater than or equal to 10 milli-international unit \[mIU\]/mL) after HEPLISAV-B
Week 4
Group
Value
95% CI
HEPLISAV-B
20.3
11.8 – 31.2
Week 8
Group
Value
95% CI
HEPLISAV-B
56.8
44.7 – 68.2
Week 16
Group
Value
95% CI
HEPLISAV-B
78.7
67.7 – 87.3
Week 20
Group
Value
95% CI
HEPLISAV-B
89.3
80.1 – 95.3
Adverse events — posted to ClinicalTrials.gov
Time frame: The reporting period for All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events begins at the time of the first study treatment from Visit 1 (Week 0) through EOS Visit (Week 68)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Other recruiting trials for End Stage Renal Disease on Hemodialysis (Diagnosis)
Currently open trials in the same condition.
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· NA
· active not recruiting
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Dynavax Technologies Corporation
Last refreshed: 9 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03934736.