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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT04684914

Run by

Altimmune, Inc.

People needed

87

Starts

2020-12-26

Expected to finish

2024-04-17

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Paragon Rx Clinical — Garden Grove, California, United States
• Stanford University Department of Medicine — Redwood City, California, United States
• San Jose Gastroenterology Institute — San Jose, California, United States
• Kansas City Research Institute — Kansas City, Missouri, United States
• Central Sooner Research — Oklahoma City, Oklahoma, United States
• University of Calgary Liver Unit - Heritage Medical Research Clinic — Calgary, Alberta, Canada
• University of Alberta Hospital — Edmonton, Alberta, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN — Toronto, Ontario, Canada
• Toronto Liver Centre — Toronto, Ontario, Canada
• Goethe University Hospital — Frankfurt am Main, Germany
• Univesritätsklinikum Hamburg-Eppendorf — Hamburg, Germany
• Hospital Clínic De Barcelona — Barcelona, Spain
• Hospital Universitari Vall D'Hebron — Barcelona, Spain
• Hospital Universitario La Paz — Madrid, Spain
• Hospital Nuestra Señora De Valme — Seville, Spain
• Consorcio Hospital General Universitario De Valencia — Valencia, Spain
• Hospital Universitari I Politècnic La Fe — Valencia, Spain
• St. Georges University of London — London, United Kingdom
• St. Mary's Hospital — London, United Kingdom
• Queens Medical Center — Nottingham, United Kingdom

Full record on ClinicalTrials.gov

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