HBV Virions Bound Proteins

NCT02798549 | Completed

• 1 other identifier: 2013.809
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis B Virus Infection

Keywords

HBV; liver

Outcome Measures

Primary Outcomes (1)

• Presence of a virion-bound protein identified by mass spectrometry

  One to two years after mass spectrometry identification of the candidate

Secondary Outcomes (1)

• Comparison of clinical virions datasets with in vitro grown virions datasets (mass spectrometry)

  One to two years after mass spectrometry identification of the candidate

Study Arms (2)

Viraemic

OTHER

Other: blood draw

Remission

OTHER

Other: blood draw

Interventions

blood draw OTHER

blood draw of 150ml, twice

Remission; Viraemic

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'Hépato-Gastroentérologie, Hopital de la Croix-Rousse, Hospices Civils de Lyon

Lyon, Auvergne-Rhône-Alpes, 69004, France

Location

Related Publications (1)

• Cottarel J, Plissonnier ML, Kullolli M, Pitteri S, Clement S, Millarte V, Si-Ahmed SN, Farhan H, Zoulim F, Parent R. FIG4 is a hepatitis C virus particle-bound protein implicated in virion morphogenesis and infectivity with cholesteryl ester modulation potential. J Gen Virol. 2016 Jan;97(1):69-81. doi: 10.1099/jgv.0.000331. Epub 2015 Oct 29.

  PMID: 26519381 BACKGROUND

MeSH Terms

Conditions

Hepatitis B

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Fabien Zoulim, Prof

  Hospices Civils de Lyon, Univ. of Lyon, Inserm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 14, 2016
• Study Start: January 12, 2015
• Primary Completion: January 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)