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Trial record 1 of 1 for:    HepTcell | Recruiting, Not yet recruiting Studies | Hepatitis
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HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)

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ClinicalTrials.gov Identifier: NCT04684914
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : September 9, 2022
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Biological: HepTcell Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 26, 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HepTcell
Dose administered at intervals of 4 weeks for 6 doses
 Biological: HepTcell
Intramuscular injection
Placebo Comparator: Placebo
Dose administered at intervals of 4 weeks for 6 doses
 Drug: Placebo
Intramuscular injection


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of patients achieving virologic responses [ Time Frame: Baseline to Day 169 ]

Secondary Outcome Measures :
  1. The proportion of patients achieving serologic clearance of Hepatitis B surface antigen (HBsAg) [ Time Frame: Baseline to Day 169 ]
  2. The proportion of patients achieving serologic clearance of Hepatitis B virus (HBV) DNA [ Time Frame: Baseline to Day 169 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684914


Contacts
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Contact: Altimmune CTM (240) 654-1450 information@altimmune.com

Locations
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Sponsors and Collaborators
Altimmune, Inc.
More Information
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Responsible Party: Altimmune, Inc.
ClinicalTrials.gov Identifier: NCT04684914    
Other Study ID Numbers: ALT-301-202
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: September 9, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Altimmune, Inc.:
Immunotherapy
CHB
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Viral, Human
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections