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

Altimmune

Status and phase: Terminated; Phase 2

Conditions: Hepatitis B, Chronic

Treatments: Drug: Placebo; Biological: HepTcell

Study type: Interventional

Funder types: Industry

Identifiers

NCT04684914

ALT-301-202

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 2 patient groups, including a placebo group

HepTcell

Experimental group

Description:

Dose administered at intervals of 4 weeks for 6 doses

Treatment:

Biological: HepTcell

Placebo

Placebo Comparator group

Description:

Dose administered at intervals of 4 weeks for 6 doses

Treatment:

Drug: Placebo