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

Hepatitis B, Chronic Clinical Trial

Official title:

Influence of Hepatitis B Virus (HBV) Envelope Glycoprotein Characteristics on HBsAg Clearance on Anti-HBV Treatment by Nucleos(t)Ide Analogues

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350074
• Other study ID #: DC 2013-1801
• 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
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

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)