Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis

NCT04588077 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-11-19

No results posted yet for this study

Summary

Investigators want to compare the seroconversion rates between two-dose and three-dose regimens of the hepatitis B vaccine (Heplisav B) among patients with cirrhosis, a randomized prospective study.

Conditions

Interventions

BIOLOGICAL

Heplisav-B Injectable Product, 2-dose regimen

Investigators will randomly assign patients into a 2-dose regimen.

BIOLOGICAL

Heplisav-B Injectable Product, 3-dose regimen

Investigators will randomly assign patients into a 3-dose regimen.

Sponsors & Collaborators

  • Mercy Medical Center

    lead OTHER

Principal Investigators

  • Paul Thuluvath, MD · Mercy Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2028-12-01
Completion
2028-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT04588077 on ClinicalTrials.gov