HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)

Launched by ALTIMMUNE, INC. · Dec 22, 2020

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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).