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

Primary Purpose

Hepatitis B, Chronic

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HepTcell
Placebo
Sponsored by
Altimmune, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Immunotherapy, CHB

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Paragon Rx Clinical
  • Stanford University Department of Medicine
  • San Jose Gastroenterology Institute
  • Kansas City Research Institute
  • Central Sooner Research
  • University of Calgary Liver Unit - Heritage Medical Research Clinic
  • University of Alberta Hospital
  • The Ottawa Hospital
  • Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN
  • Toronto Liver Centre
  • Goethe University Hospital
  • Univesritätsklinikum Hamburg-Eppendorf
  • Hospital Clínic De Barcelona
  • Hospital Universitari Vall D'Hebron
  • Hospital Universitario La Paz
  • Hospital Nuestra Señora De Valme
  • Consorcio Hospital General Universitario De Valencia
  • Hospital Universitari I Politècnic La Fe
  • St. Georges University of London
  • St. Mary's Hospital
  • Queens Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HepTcell

Placebo

Arm Description

Dose administered at intervals of 4 weeks for 6 doses

Dose administered at intervals of 4 weeks for 6 doses

Outcomes

Primary Outcome Measures

The proportion of patients achieving virologic responses

Secondary Outcome Measures

The proportion of patients achieving serologic clearance of Hepatitis B surface antigen (HBsAg)
The proportion of patients achieving serologic clearance of Hepatitis B virus (HBV) DNA

Full Information

First Posted
December 22, 2020
Last Updated
July 25, 2023
Sponsor
Altimmune, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04684914
Brief Title
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 26, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Altimmune, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Immunotherapy, CHB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HepTcell
Arm Type
Experimental
Arm Description
Dose administered at intervals of 4 weeks for 6 doses
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Dose administered at intervals of 4 weeks for 6 doses
Intervention Type
Biological
Intervention Name(s)
HepTcell
Intervention Description
Intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection
Primary Outcome Measure Information:
Title
The proportion of patients achieving virologic responses
Time Frame
Baseline to Day 169
Secondary Outcome Measure Information:
Title
The proportion of patients achieving serologic clearance of Hepatitis B surface antigen (HBsAg)
Time Frame
Baseline to Day 169
Title
The proportion of patients achieving serologic clearance of Hepatitis B virus (HBV) DNA
Time Frame
Baseline to Day 169

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Paragon Rx Clinical
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Stanford University Department of Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
San Jose Gastroenterology Institute
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Central Sooner Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
University of Calgary Liver Unit - Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Liver Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
Facility Name
Goethe University Hospital
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Univesritätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Hospital Clínic De Barcelona
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Nuestra Señora De Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Consorcio Hospital General Universitario De Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitari I Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
St. Georges University of London
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Queens Medical Center
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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