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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Mercy Medical Center
Study ID
NCT04588077
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Heplisav-B Injectable Product, 2-dose regimen — BIOLOGICAL
    Investigators will randomly assign patients into a 2-dose regimen.
  • Heplisav-B Injectable Product, 3-dose regimen — BIOLOGICAL
    Investigators will randomly assign patients into a 3-dose regimen.

Study Details

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.

Key Dates

Start date
Sep 14, 2020
Status verified
Nov 2024
Primary completion
Dec 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Cirrhosis, 3-dose regimen
    Investigators will randomize the patient in the cirrhotic group to receive a 3-dose regimen of Heplisav-B.
  • Active Comparator: Cirrhosis, 2-dose regimen
    Investigators will randomize the patient in the cirrhotic group to receive a 2-dose regimen of Heplisav-B.
  • Experimental: Non cirrhosis, 3-dose regimen
    Investigators will randomize the patient in the noncirrhotic group to receive a 3-dose regimen of Heplisav-B.
  • Active Comparator: Non cirrhosis, 2-dose regimen
    Investigators will randomize the patient in the noncirrhotic group to receive a 2-dose regimen of Heplisav-B.

Primary Outcome Measure

The rates of seroconversion after two doses of Heplisav-B given at 0 and 4 weeks versus three doses of Heplisav-B given at 0, 4 weeks, and 8 weeks. [ Time Frame: 12 weeks after completing Heplisav-B series with two doses or three doses ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mercy Medical CenterBaltimoreMaryland21202
CHAU TO, MD
[email protected]
714-400-1331
PAUL THULUVATH, MD
[email protected]
(410)-332-9308

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