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Vaccine
Heplisav-B for Liver Cirrhosis
Phase 4
Recruiting
Led By Paul Thuluvath, MD
Research Sponsored by Mercy Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing if the hepatitis B vaccine is more effective when given in two doses or three doses for people with cirrhosis.
Who is the study for?
This trial is for adults over 18 with cirrhosis who visit Mercy Medical Center's hepatology clinic and lack immunity to Hepatitis B. It excludes those allergic to the hepatitis B vaccine or its components, yeast, previous hepatitis B exposure, post liver transplant patients, and anyone under 18.
What is being tested?
The study aims to compare how well two different dosing schedules of Heplisav B (a hepatitis B vaccine) work in patients with cirrhosis. One group will receive a two-dose regimen while another will get three doses to see which provides better protection.
What are the potential side effects?
Possible side effects from Heplisav B may include pain at the injection site, fatigue, headache, irritability in infants and toddlers after vaccination; serious allergic reactions are rare but can occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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.
Secondary study objectives
Factors are associated with a lower likelihood of achieving immunogenicity, such as age, race, MELD scores, etiologies of cirrhosis, comorbidity, immunosuppressive drugs. Those information will be measured or described descriptively by chart review.
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Non cirrhosis, 3-dose regimenExperimental Treatment1 Intervention
Investigators will randomize the patient in the noncirrhotic group to receive a 3-dose regimen of Heplisav-B.
Group II: Cirrhosis, 3-dose regimenExperimental Treatment1 Intervention
Investigators will randomize the patient in the cirrhotic group to receive a 3-dose regimen of Heplisav-B.
Group III: Cirrhosis, 2-dose regimenActive Control1 Intervention
Investigators will randomize the patient in the cirrhotic group to receive a 2-dose regimen of Heplisav-B.
Group IV: Non cirrhosis, 2-dose regimenActive Control1 Intervention
Investigators will randomize the patient in the noncirrhotic group to receive a 2-dose regimen of Heplisav-B.
Find a Location
Who is running the clinical trial?
Mercy Medical CenterLead Sponsor
20 Previous Clinical Trials
4,022 Total Patients Enrolled
Paul Thuluvath, MD4.712 ReviewsPrincipal Investigator - Mercy Medical Center
Mercy Medical Center
1 Previous Clinical Trials
151 Total Patients Enrolled
5Patient Review
I would recommend Dr. Thuluvath to anyone seeking a trustworthy, competent physician. He is kind and takes the time to ensure his patients understand their conditions and treatment options.