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

Hepatitis B, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04684914
• Other study ID #: ALT-301-202
• Status: Terminated
• Phase: Phase 2
• Start date: December 26, 2020
• Est. completion date: April 17, 2024

Study information

• Verified date: May 2024
• Source: Altimmune, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 87
• Est. completion date: April 17, 2024
• Est. primary completion date: March 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Biological:
• HepTcell
Intramuscular injection

Drug:
• Placebo
Intramuscular injection

Locations

Country	Name	City	State
Canada	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
Germany	Goethe University Hospital	Frankfurt am Main
Germany	Univesritätsklinikum Hamburg-Eppendorf	Hamburg
Spain	Hospital Clínic De Barcelona	Barcelona
Spain	Hospital Universitari Vall D'Hebron	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Nuestra Señora De Valme	Sevilla
Spain	Consorcio Hospital General Universitario De Valencia	Valencia
Spain	Hospital Universitari I Politècnic La Fe	Valencia
United Kingdom	St. Georges University of London	London
United Kingdom	St. Mary's Hospital	London
United Kingdom	Queens Medical Center	Nottingham
United States	Paragon Rx Clinical	Garden Grove	California
United States	Kansas City Research Institute	Kansas City	Missouri
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Altimmune, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients achieving virologic responses		Baseline to Day 169
Secondary	The proportion of patients achieving serologic clearance of Hepatitis B surface antigen (HBsAg)		Baseline to Day 169
Secondary	The proportion of patients achieving serologic clearance of Hepatitis B virus (HBV) DNA		Baseline to Day 169