HBV Envelope Proteins Variability on HBs Antigen Clearance Under Nucleos(t)Ide Analogue Therapy
Influence of Hepatitis B Virus (HBV) Envelope Glycoprotein Characteristics on HBsAg Clearance on Anti-HBV Treatment by Nucleos(t)Ide Analogues
1 other identifier
observational
19
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2013
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
September 29, 2017
CompletedFirst Posted
Study publicly available on registry
November 22, 2017
CompletedNovember 22, 2017
September 1, 2017
2.5 years
September 29, 2017
November 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clearance of Hepatitis B surface antigen (HBsAg)
Subgroup of patients infected by HBV genotype D
May 2016 (manuscript Velay et al., 2016)
Secondary Outcomes (1)
Clearance of Hepatitis B surface antigen (HBsAg)
September 2017 (manuscript Eschlimann et al., 2017)
Eligibility Criteria
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).
You may qualify if:
- adults
- patients with chronic hepatitis B
- treated with nucleos(t)ide analogues
- mono-infected with HBV (without co-infection with HCV, HIV and HDV)
You may not qualify if:
- minor
- pregnant women
- patients with VHC or VHD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
DNA VHB VIRUS
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2017
First Posted
November 22, 2017
Study Start
November 5, 2013
Primary Completion
May 1, 2016
Study Completion
September 1, 2017
Last Updated
November 22, 2017
Record last verified: 2017-09