HepTcell Immunotherapy for Chronic Hepatitis B

Phase 2

Waitlist Available

Research Sponsored by Altimmune, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women 18 to 65 years of age, inclusive

Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1

Must not have

How much do you weigh in pounds?

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing HepTcell, a treatment that helps the immune system fight Hepatitis B. It focuses on patients who have not been treated before and have a less active form of the virus. The goal is to see if HepTcell can safely improve their immune response and reduce the virus levels.

Who is the study for?

This trial is for men and women aged 18 to 65 with inactive Chronic Hepatitis B, who haven't been treated before. Participants should have specific levels of HBsAg and HBV DNA, normal liver function tests, and must have had CHB for at least a year.

What is being tested?

The study is testing the effects of a new treatment called HepTcell compared to a placebo in patients with inactive CHB. It aims to see if HepTcell can help control the virus better and how safe it is.

What are the potential side effects?

Possible side effects from HepTcell could include typical immune response symptoms like fever or fatigue, injection site reactions, or changes in liver enzymes. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have had inactive hepatitis B for at least a year.

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The amount of a certain virus in your blood called qHBsAg is too high or too low for you to participate in the study.

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You have high levels of HBV DNA in your blood sample taken during the screening process.

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Your liver function tests, including AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome), and direct bilirubin, should be within normal limits at the time of screening.

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The given statement is not a screening criterion. It is a direct question asking for the participant's height in inches.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh... pounds.