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
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
- Hepatitis B
- Cirrhosis, Liver
- Chronic Liver Disease
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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