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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03350074
Other study ID # DC 2013-1801
Secondary ID
Status Completed
Phase N/A
First received September 29, 2017
Last updated November 20, 2017
Start date November 5, 2013
Est. completion date September 1, 2017

Study information

Verified date September 2017
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date September 1, 2017
Est. primary completion date May 1, 2016
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome

Type Measure Description Time frame Safety issue
Primary Clearance of Hepatitis B surface antigen (HBsAg) Subgroup of patients infected by HBV genotype D May 2016 (manuscript Velay et al., 2016)
Secondary Clearance of Hepatitis B surface antigen (HBsAg) Subgroup of patients infected by HBV genotype A September 2017 (manuscript Eschlimann et al., 2017)
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