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CompletedNCT03350074Updated Nov 22, 2017

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

An observational study in Hepatitis B, Chronic, sponsored by Central Hospital, Nancy, France. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-22.

Sponsored by Central Hospital, Nancy, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
19
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Hepatitis B, Chronic

Keywords

  • Hepatitis B virus
  • PreS/S variability
  • Anti-HBV treatment
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).

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

Exclusion Criteria:

  • minor
  • pregnant women
  • patients with VHC or VHD
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
19 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

Primary outcomes

  1. Clearance of Hepatitis B surface antigen (HBsAg)

    Subgroup of patients infected by HBV genotype D

    Time frame: May 2016 (manuscript Velay et al., 2016)

Secondary outcomes

  1. Clearance of Hepatitis B surface antigen (HBsAg)

    Subgroup of patients infected by HBV genotype A

    Time frame: September 2017 (manuscript Eschlimann et al., 2017)

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03350074
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Nov 22, 2017
Start date
Nov 5, 2013
Primary completion
May 1, 2016
Completion
Sep 1, 2017
Last update
Nov 22, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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