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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

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.

Do I qualify?Apply below to find out

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.