Hepatitis CNCT02795403
HCV Virions Bound Proteins
A study testing blood draw of 150ml, twice in people with Hepatitis C, run by Hospices Civils de Lyon at 1 site in France.
Trial 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 C virus (HCV). HCV particles acquire via budding and encapsidation cellular proteins. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- blood draw of 150ml, twice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult> 18 and <60 years
- Infected with HCV genotype 1 HCV antibody positive.
- positive viremia for more than 6 months
- Viremia> 106 IU / ml.
- nonresponders to previous treatment and without antiviral treatment for 2 months.
- For control samples: Patients responders to previous treatment and without antiviral treatment for 2 months.
Who cannot join
- Patient receiving or having received antiviral treatment within two months.
- patient with against-indication for a blood sample of 150 ml
- immunosuppressive therapy patient
- Patient with liver disease other than hepatitis C.
- Patients with cirrhosis.
- patient with hepatocellular carcinoma.
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- Patients with one or more severe co-morbidities defined as:
- Co-infection with HIV or HBV.
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Hépato-Gastroentérologie Lyon Croix-Rousse Hospices Civils de Lyon
Lyon, 69004
About this study
Official title: Hepatitis C 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 C virus (HCV). HCV 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 HCV 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 HCV virions in clinical samples, followed by the identification of their HCV-bound host proteins and the characterization of their functions. Proteomics profiling of HCV particles purified from clinical samples will be overlaid with proteins identified and characterized in cell culture grown HCV particles during my post-doctoral training, using clinical biomarker discovery grade criteria. Targets identified in both samples sets will be subjected to in vitro investigations using HCV-replicating cells. Conventional biochemical and imaging methods will be used in order to: (i) ascertain their physical association with HCV virions; (ii) define the modalities of their interaction with HCV proteins; (iii) decipher the topology and subcellular localization of their association with HCV 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 C
- Being tested
- blood draw of 150ml, twice
- Keywords
- HCV, liver
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood draw of 150ml, twiceOther
| Study group | Role | What they receive |
|---|---|---|
| Viraemic | Experimental | Not described Receives: Other: blood draw of 150ml, twice |
| responder group | Experimental | Not described Receives: Other: blood draw of 150ml, twice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative identification (unit used: Protein Prophet score) of a given virion-bound protein in purified virions preparations
Protein prophet scores allow one to estimate the robustness of identification of a given protein in MS approaches.
Measured: One to two years after mass spectrometry identification of the candidate
Quantitative evaluation of its implication in viral morphogenesis (unit used: TCID50).
TCID50 units are infectivity units routinely used in HCV research for viral infectivity quantification.
Measured: One to two years after mass spectrometry identification of the candidate
Quantitative evaluation of viral entry (unit used: HCV RNA /GUS mRNA copy ratios).
HCV RNA /GUS mRNA copy ratios are derived from the 2^delta(delta Ct) method.
Measured: 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
Proteins identified from viral particles purified from clinical samples will be compared to proteins identified in viral particles from cells of human hepatocarcinoma (Huh7.5) infected with HCV and from which data are published.
Measured: One to two years after mass spectrometry identification of the candidate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startJan 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien ZOULIM, MD, Principal investigator, Service d'Hépato-Gastroentérologie Lyon Croix-Rousse Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795403
- Sponsor's protocol ID
- 2009-596
- Status last verified
- Aug 2025
- First submitted
- 17 May 2016
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26519381
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Virus Particles-bound Human Proteins : Identification in Clinical Samples and Implication in the Viral Life Cycle
- ClinicalTrials.gov ID
- NCT02795403
- Acronym / sponsor ID
- 2009-596
- Conditions
- Hepatitis C
- Keywords
- HCV, liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 C virus (HCV). HCV 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 HCV 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 HCV virions in clinical samples, followed by the identification of their HCV-bound host proteins and the characterization of their functions. Proteomics profiling of HCV particles purified from clinical samples will be overlaid with proteins identified and characterized in cell culture grown HCV particles during my post-doctoral training, using clinical biomarker discovery grade criteria. Targets identified in both samples sets will be subjected to in vitro investigations using HCV-replicating cells. Conventional biochemical and imaging methods will be used in order to: (i) ascertain their physical association with HCV virions; (ii) define the modalities of their interaction with HCV proteins; (iii) decipher the topology and subcellular localization of their association with HCV 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viraemic | Experimental | Other: blood draw of 150ml, twice |
| responder group | Experimental | Other: blood draw of 150ml, twice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult> 18 and <60 years
- Infected with HCV genotype 1 HCV antibody positive.
- positive viremia for more than 6 months
- Viremia> 106 IU / ml.
- nonresponders to previous treatment and without antiviral treatment for 2 months.
Key exclusion criteria (14 listed)
- Patient receiving or having received antiviral treatment within two months.
- patient with against-indication for a blood sample of 150 ml
- immunosuppressive therapy patient
- Patient with liver disease other than hepatitis C.
- Patients with cirrhosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draw of 150ml, twice | Other | Viraemic, responder group |
Primary outcome
Qualitative identification (unit used: Protein Prophet score) of a given virion-bound protein in purified virions preparations
Time frame: One to two years after mass spectrometry identification of the candidate
Protein prophet scores allow one to estimate the robustness of identification of a given protein in MS approaches.
Quantitative evaluation of its implication in viral morphogenesis (unit used: TCID50).
Time frame: One to two years after mass spectrometry identification of the candidate
TCID50 units are infectivity units routinely used in HCV research for viral infectivity quantification.
Quantitative evaluation of viral entry (unit used: HCV RNA /GUS mRNA copy ratios).
Time frame: One to two years after mass spectrometry identification of the candidate
HCV RNA /GUS mRNA copy ratios are derived from the 2^delta(delta Ct) method.
1 secondary outcome
Comparison of clinical virions datasets with in vitro grown virions datasets
Time frame: One to two years after mass spectrometry identification of the candidate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 26519381Cottarel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien ZOULIM, MD principal investigator
Service d'Hépato-Gastroentérologie Lyon Croix-Rousse Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood draw of 150ml, twice in people with Hepatitis C, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative identification (unit used: Protein Prophet score) of a given virion-bound protein in purified virions preparations (time frame: One to two years after mass spectrometry identification of the candidate). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.