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

NCT04684914 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: ALT-301-202
• Study Type: interventional
• Target: 87
• Locations: 5 countries
• Sites: 21

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.

Conditions

Hepatitis B, Chronic

Keywords

Immunotherapy; CHB

Outcome Measures

Primary Outcomes (1)

• The Proportion of Patients Achieving Virologic Responses

  Virologic response is defined as a 1.0-log reduction in quantitative hepatitis B surface antigen (HBsAg) or serologic clearance of HBsAg from Baseline to Day 169

  Baseline to Day 169

Secondary Outcomes (7)

• The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Surface Antigen (HBsAg) on Day 169

  Baseline to Day 169

• The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Virus (HBV) DNA on Day 169

  Baseline to Day 169

• Changes in Quantitative HBsAg Level

  Baseline to Days 85 and 169

• Changes in HBV DNA Levels

  Baseline to Days 85 and 169

• Changes in Hepatitis B Core-related Antigen (HBCrAg) Levels

  Baseline to Days 85 and 169

Study Arms (2)

HepTcell

EXPERIMENTAL

Dose administered at intervals of 4 weeks for 6 doses

Biological: HepTcell

Placebo

PLACEBO COMPARATOR

Dose administered at intervals of 4 weeks for 6 doses

Drug: Placebo

Interventions

HepTcell BIOLOGICAL

Intramuscular injection

HepTcell

Placebo DRUG

Intramuscular injection

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Altimmune, Inc.: lead

Study Sites (21)

Paragon Rx Clinical

Garden Grove, California, 92840, United States

Location

Stanford University Department of Medicine

Redwood City, California, 94063, United States

Location

San Jose Gastroenterology Institute

San Jose, California, 95128, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

Central Sooner Research

Oklahoma City, Oklahoma, 73071, United States

Location

University of Calgary Liver Unit - Heritage Medical Research Clinic

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2G3, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN

Toronto, Ontario, M5G 2C4, Canada

Location

Toronto Liver Centre

Toronto, Ontario, M6H 3M1, Canada

Location

Goethe University Hospital

Frankfurt am Main, 60590, Germany

Location

Univesritätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Hospital Clínic De Barcelona

Barcelona, 08028, Spain

Location

Hospital Universitari Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Nuestra Señora De Valme

Seville, 41014, Spain

Location

Consorcio Hospital General Universitario De Valencia

Valencia, 46014, Spain

Location

Hospital Universitari I Politècnic La Fe

Valencia, 46026, Spain

Location

St. Georges University of London

London, SW17 0RE, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

Queens Medical Center

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Randy Brown
• Organization: Altimmune

rbrown@altimmune.com

3179003335

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: December 26, 2020
• Primary Completion: March 27, 2024
• Study Completion: April 17, 2024
• Last Updated: December 8, 2025
• Results First Posted: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6); GB (3); CA (5); US (5); DE (2)