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

Phase 2, Double-blind, Randomized, Placebo-controlled Study of HepTcell (Adjuvanted FP-02.2) as an Immunotherapeutic Vaccine in Treatment-naïve Patients With Inactive Chronic Hepatitis B (CHB)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: Placebo; Biological: HepTcell

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Altimmune CTM; Phone Number: (240) 654-1450; Email: information@altimmune.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary Liver Unit - Heritage Medical Research Clinic
    • Edmonton, Alberta, Canada, T6G 2G3
      • University of Alberta Hospital
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital
    • Toronto, Ontario, Canada, M6H 3M1
      • Toronto Liver Centre
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN
• Germany
  • Frankfurt am Main, Germany, 60590
    • Goethe University Hospital
  • Hamburg, Germany, 20246
    • Univesritätsklinikum Hamburg-Eppendorf
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'hebron
  • Barcelona, Spain, 08028
    • Hospital Clinic de Barcelona
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Sevilla, Spain, 41014
    • Hospital Nuestra Senora de Valme
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario de Valencia
• United Kingdom
  • London, United Kingdom, W2 1NY
    • St. Mary's Hospital
  • London, United Kingdom, SW17 0RE
    • St. Georges University of London
  • Nottingham, United Kingdom, NG7 2UH
    • Queens Medical Center
• United States
  • California
    • Garden Grove, California, United States, 92840
      • Paragon Rx Clinical
    • Redwood City, California, United States, 94063
      • Stanford University Department of Medicine
    • San Jose, California, United States, 95128
      • San Jose Gastroenterology Institute
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Research Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73071
      • Central Sooner Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HepTcell; Dose administered at intervals of 4 weeks for 6 doses	Biological: HepTcell; Intramuscular injection
Placebo Comparator: Placebo; Dose administered at intervals of 4 weeks for 6 doses	Drug: Placebo; Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients achieving virologic responses	Baseline to Day 169

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Altimmune, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 26, 2020
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Immunotherapy; CHB
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic
• Other Study ID Numbers: ALT-301-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No