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

Phase 2

Terminated

• Conditions: Hepatitis B, Chronic
• Interventions: Biological: HepTcell; Drug: Placebo

• Registration Number: NCT04684914
• Lead Sponsor: Altimmune, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-22
• Study Start: 2020-12-26
• Study First Posted: 2020-12-28
• Primary Completion: 2024-03-27
• Study Completion: 2024-04-17
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 87

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HepTcell	HepTcell	Dose administered at intervals of 4 weeks for 6 doses
Placebo	Placebo	Dose administered at intervals of 4 weeks for 6 doses

Primary Outcome Measures

Name	Time	Method
The proportion of patients achieving virologic responses	Baseline to Day 169

Secondary Outcome Measures

Name	Time	Method
The proportion of patients achieving serologic clearance of Hepatitis B surface antigen (HBsAg)	Baseline to Day 169
The proportion of patients achieving serologic clearance of Hepatitis B virus (HBV) DNA	Baseline to Day 169

Trial Locations

Locations (21)

Queens Medical Center; 🇬🇧 Nottingham, United Kingdom

St. Georges University of London; 🇬🇧 London, United Kingdom

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

St. Mary's Hospital; 🇬🇧 London, United Kingdom

Hospital Universitari I Politècnic La Fe; 🇪🇸 Valencia, Spain

Central Sooner Research; 🇺🇸 Oklahoma City, Oklahoma, United States

Stanford University Department of Medicine; 🇺🇸 Redwood City, California, United States

San Jose Gastroenterology Institute; 🇺🇸 San Jose, California, United States

Paragon Rx Clinical; 🇺🇸 Garden Grove, California, United States

University of Calgary Liver Unit - Heritage Medical Research Clinic; 🇨🇦 Calgary, Alberta, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Goethe University Hospital; 🇩🇪 Frankfurt am Main, Germany

Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN; 🇨🇦 Toronto, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Hospital Clínic De Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

Consorcio Hospital General Universitario De Valencia; 🇪🇸 Valencia, Spain

Toronto Liver Centre; 🇨🇦 Toronto, Ontario, Canada

Univesritätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Hospital Nuestra Señora De Valme; 🇪🇸 Sevilla, Spain

Kansas City Research Institute; 🇺🇸 Kansas City, Missouri, United States