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NCT04588077RecruitingPhase 4

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

Comparison the Seroconversion Rate Between Two-dose and Three-dose Regimens of Heplisav B Among Patients With Cirrhosis, a Randomized-control Prospective Study.

Source: ClinicalTrials.gov · Last updated 19 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
200 (estimated)
First submitted
18 Sept 2020
Start date
14 Sept 2020
Primary completion date
1 Dec 2028
Lead sponsor
Mercy Medical Center
Diseases
Hepatitis B
NCT number
NCT04588077

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 200
  • From 14 Sept 2020 to the primary completion date, 1 Dec 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Anyone who has had a serious allergic reaction to a prior dose of the hepatitis B vaccine, a component of the hepatitis B vaccine, or yeast should not receive the hepatitis B vaccine.
  • Those who had previous exposure to hepatitis B.
  • Post liver transplant patients.

Age

  • Less than 18 years old.

Who the study is looking for

  • \- All the cirrhosis patients more than 18 years old presented to the hepatology clinic in Mercy Medical Center between 09/2020 and 07/2021 who do not have immunity against Hepatitis B (defined as anti-HBs titer \< 10 mIU/ml) will be recruited.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mercy Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.