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

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.

Timeline

Start

2020-12-26

Primary completion

2024-03-27

Completion

2024-04-17

Outcome

Missed primary endpoint

Stopped: “Did not meet endpoints”

registry analysis (superiority test); HepTcell vs Placebo; p = 0.3029; Chi-squared NCT04684914 ↗

registry analysis (superiority test); HepTcell vs Placebo; p = 0.4881; Fisher Exact NCT04684914 ↗

release “The overall response in the Phase 2 trial was deemed to be insufficient to warrant further advancement.” altimmune.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HepTcell	Vaccine	—	Intramuscular

Indications