HBV Virions Bound Proteins

September 11, 2018 updated by: Hospices Civils de Lyon

Hepatitis B Virus Particles-bound Human Proteins : Identification in Clinical Samples and Implication in the Viral Life Cycle

The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough understanding of the biology of one of its major causative agents, the hepatitis B virus (HBV). HBV particles acquire via budding and encapsidation cellular proteins. There is mounting evidence on several viral species that virion-bound proteins are prone to be involved either at the replication, budding/egress or entry/release steps of the viral cycle.

Identifying such targets may yield ideal candidates for gaining insight on the dependence of HBV upon a restricted subset of host proteins, therefore providing refined sets of genetically stable targets for therapy. This project's goals are to set up adequate conditions for robust and reproducible purification of HBV virions in clinical samples, followed by the identification of their HBV-bound host proteins and the characterization of their functions. Proteomics profiling of HBV particles purified from clinical samples will be overlaid with proteins identified and characterized in cell culture grown HBV particles, using clinical biomarker discovery grade criteria. Targets identified in both samples sets will be subjected to in vitro investigations using HBV-replicating cells. Conventional biochemical and imaging methods will be used in order to: (i) ascertain their physical association with HBV virions; (ii) define the modalities of their interaction with HBV proteins; (iii) decipher the topology and subcellular localization of their association with HBV proteins and virions; (iv) quantitatively assess their functional involvement in particle budding, egress or secretion and infectivity. A candidate that yielded satisfactory results in these experiments will be disclosed and further investigated at the level of structural biology, in collaborative research programs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69004
        • Service d'Hépato-Gastroentérologie, Hopital de la Croix-Rousse, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inclusion criteria
  • Adult> 18 and <60 years
  • Infected with HBV.
  • positive viremia for more than 6 months
  • Viremia> 106 IU / ml.
  • Immunotolerant individuals, untreated
  • Aviraemic individuals,

Exclusion Criteria:

  • patient with against-indication for a blood sample of 150 ml
  • immunosuppressive therapy patient
  • Patient with liver disease other than hepatitis B.
  • patient with hepatocellular carcinoma.
  • Patients with one or more severe co-morbidities defined as:
  • Co-infection with HIV or hepatitis C virus (HCV).
  • hematological malignancies changing or aplasia
  • Insulin-dependent diabetes
  • dialyzed chronic renal failure
  • Heart failure
  • Persons subject to legal protection or the subject of a safeguard measure of justice
  • not affiliated with a social security scheme or not beneficiaries of such a scheme
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Viraemic
Other: blood draw
blood draw of 150ml, twice
Other: Remission
Other: blood draw
blood draw of 150ml, twice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of a virion-bound protein identified by mass spectrometry
Time Frame: One to two years after mass spectrometry identification of the candidate
One to two years after mass spectrometry identification of the candidate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of clinical virions datasets with in vitro grown virions datasets (mass spectrometry)
Time Frame: One to two years after mass spectrometry identification of the candidate
Proteins identified from viral particles purified from clinical samples will be compared to proteins identified in viral particles from cells of human hepatocarcinoma origin.
One to two years after mass spectrometry identification of the candidate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Fabien Zoulim, Prof, Hospices Civils de Lyon, Univ. of Lyon, Inserm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

May 30, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013.809

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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