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HBV Envelope Proteins Variability on HBs Antigen Clearance Under Nucleos(t)Ide Analogue Therapy

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ClinicalTrials.gov Identifier: NCT03350074
Recruitment Status : Completed
First Posted : November 22, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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Brief Summary:
Hepatitis B virus (HBV) infection remains difficult to eradicate with about 240 million people living with HBV chronic infection. HBsAg clearance, correlated with a good clinical prognosis, is difficult to achieve even with antiviral treatments (3-14 %). HBV envelope proteins are essential for entry into hepatocyte and are targeted by the immune system. Molecular characteristics of HBV envelope proteins may favour better viral fitness at the entry step into hepatocytes and/or HBV escape from host immunity. Here we investigated whether variability of HBV envelope proteins can contribute to the differential responses to anti-HBV treatment in patients with HBsAg clearance or persistence.

Condition or disease
Hepatitis B, Chronic

Detailed Description:
Our study is a retrospective study of patients with chronic hepatitis B virus, selected exclusively at the University Hospital Center of Nancy in the Department of Hepato-Gastroenterology (HGE). the patient inclusion criteria were as follows: Adult patients with chronic hepatitis B, treated with nucleos(t)ide analogues, mono-infected with HBV (without co-infection with HCV, HIV and HDV). For each patient included, biological, clinical and therapeutic data were collected retrospectively. Patients with loss of viral load on treatment were included in this study. Among them, patients showed either a clearance of HBsAg on treatment ("responders") or the control patients showed a persistence of HBsAg on treatment ("non-responders", control patients).
Study Design
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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Influence of Hepatitis B Virus (HBV) Envelope Glycoprotein Characteristics on HBsAg Clearance on Anti-HBV Treatment by Nucleos(t)Ide Analogues
Actual Study Start Date : November 5, 2013
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : September 1, 2017

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Clearance of Hepatitis B surface antigen (HBsAg) [ Time Frame: May 2016 (manuscript Velay et al., 2016) ]
    Subgroup of patients infected by HBV genotype D


Secondary Outcome Measures :
  1. Clearance of Hepatitis B surface antigen (HBsAg) [ Time Frame: September 2017 (manuscript Eschlimann et al., 2017) ]
    Subgroup of patients infected by HBV genotype A


Biospecimen Retention:   Samples With DNA
DNA VHB VIRUS

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Our study is a retrospective study of patients with chronic hepatitis B virus, selected exclusively at the University Hospital Center of Nancy in the Department of Hepato-Gastroenterology (HGE). the patient inclusion criteria were as follows: Adult patients with chronic hepatitis B, treated with nucleos(t)ide analogues, mono-infected with HBV (without co-infection with HCV, HIV and HDV). For each patient included, biological, clinical and therapeutic data were collected retrospectively. Patients with loss of viral load on treatment were included in this study. Among them, patients showed either a clearance of HBsAg on treatment ("responders") or the control patients showed a persistence of HBsAg on treatment ("non-responders", control patients).
Criteria

Inclusion Criteria:

  • adults
  • patients with chronic hepatitis B
  • treated with nucleos(t)ide analogues
  • mono-infected with HBV (without co-infection with HCV, HIV and HDV)

Exclusion Criteria:

  • minor
  • pregnant women
  • patients with VHC or VHD
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03350074    
Other Study ID Numbers: DC 2013-1801
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Hepatitis B virus
PreS/S variability
Anti-HBV treatment
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
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic