Phase 2, Double-blind, Randomized, Placebo-controlled Study of HepTcell (Adjuvanted FP-02.2) as an Immunotherapeutic Vaccine in Treatment-naïve Patients With Inactive Chronic Hepatitis B (CHB)

  • STATUS
    Recruiting
  • End date
    Jul 14, 2023
  • participants needed
    80
  • sponsor
    Altimmune, Inc.
Updated on 14 September 2022

Summary

A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive Chronic Hepatitis B (CHB) and low Hepatitis B surface antigen (HBsAg) levels.

Details
Condition Hepatitis B, Chronic
Treatment Placebo, HepTcell
Clinical Study IdentifierNCT04684914
SponsorAltimmune, Inc.
Last Modified on14 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women 18 to 65 years of age, inclusive
Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1
qHBsAg ≥ 10 IU/mL but ≤ 100 IU/mL in the 12 months prior to screening
HBV DNA ≥ 10 IU/mL at screening
AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome) and direct bilirubin within normal limits at screening

Exclusion Criteria

Positive hepatitis B e antigen (HBeAg) at screening
History of a hepatitis B flare or 1-log increase in HBV DNA or HBsAg in the prior 12 months
Undetectable HBV DNA at screening
Fibroscan > 8.5 kPA at screening, or history of hepatic fibrosis or cirrhosis (NB, a Fibroscan is not required if an examination is performed within 12 months or a liver biopsy was performed within 2 years before Screening and no fibrosis [F1 or greater] was identified)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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