Clinical trial NCT04684914: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatitis B, Chronic
Keywords: Immunotherapy
CHB
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-28
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: The proportion of patients achieving virologic responses
timeFrame: Baseline to Day 169
Secondary outcomes:
measure: The proportion of patients achieving serologic clearance of Hepatitis B surface antigen (HBsAg)
timeFrame: Baseline to Day 169
measure: The proportion of patients achieving serologic clearance of Hepatitis B virus (HBV) DNA
timeFrame: Baseline to Day 169
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Paragon Rx Clinical
state: California
city: Redwood City
country: United States
facility: Stanford University Department of Medicine
state: California
city: San Jose
country: United States
facility: San Jose Gastroenterology Institute
state: California
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Calgary
country: Canada
facility: University of Calgary Liver Unit - Heritage Medical Research Clinic
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Centre for Liver Disease (TCLD), Toronto General Hospital, UHN
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Frankfurt am Main
country: Germany
facility: Goethe University Hospital
city: Hamburg
country: Germany
facility: Univesritätsklinikum Hamburg-Eppendorf
city: Barcelona
country: Spain
facility: Hospital Clínic De Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Nuestra Señora De Valme
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario De Valencia
city: Valencia
country: Spain
facility: Hospital Universitari I Politècnic La Fe
city: London
country: United Kingdom
facility: St. Georges University of London
city: London
country: United Kingdom
facility: St. Mary's Hospital
city: Nottingham
country: United Kingdom
facility: Queens Medical Center
Study officials:
References: