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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 : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Altimmune, Inc.

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

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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 : March 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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).

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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United States, Oklahoma
Central Sooner Research Recruiting
Oklahoma City, Oklahoma, United States, 73071
Contact: Robert Gordon         
Sponsors and Collaborators
Altimmune, Inc.
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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: January 19, 2021
Last Verified: January 2021
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
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic