HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)
NCT ID: NCT04684914
Last Updated: 2025-12-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
87 participants
INTERVENTIONAL
2020-12-26
2024-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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HepTcell
Dose administered at intervals of 4 weeks for 6 doses
HepTcell
Intramuscular injection
Placebo
Dose administered at intervals of 4 weeks for 6 doses
Placebo
Intramuscular injection
Interventions
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HepTcell
Intramuscular injection
Placebo
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
65 Years
ALL
No
Sponsors
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Altimmune, Inc.
INDUSTRY
Responsible Party
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Locations
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Paragon Rx Clinical
Garden Grove, California, United States
Stanford University Department of Medicine
Redwood City, California, United States
San Jose Gastroenterology Institute
San Jose, California, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Central Sooner Research
Oklahoma City, Oklahoma, United States
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, Canada
Goethe University Hospital
Frankfurt am Main, , Germany
Univesritätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Hospital Clínic De Barcelona
Barcelona, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Nuestra Señora De Valme
Seville, , Spain
Consorcio Hospital General Universitario De Valencia
Valencia, , Spain
Hospital Universitari I Politècnic La Fe
Valencia, , Spain
St. Georges University of London
London, , United Kingdom
St. Mary's Hospital
London, , United Kingdom
Queens Medical Center
Nottingham, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ALT-301-202
Identifier Type: -
Identifier Source: org_study_id
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