Hepatitis CNCT02877199
Anti-E1E2 Antibodies (D32.10 Epitope-binding Antibodies) and HCV Triple Therapy
An observational study of Hepatitis C, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Triple therapy
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Apr 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatitis C virus infected patients with cirrhosis
Who may be able to join
- HCV patients with compensated cirrhosis (Child-Pugh A)
- HCV genotype 1
- non-responders to a previous course of interferon (IFN)/ribavirin
- receiving boceprevir or telaprevir
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-E1E2 Antibodies for the Prediction of Virological Response to Triple Therapy in Treatment-experienced Hepatitis C Virus-cirrhosis Cases
The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.
- Conditions
- Hepatitis C
- Being tested
- Triple therapy
- Keywords
- Hepatitis C, anti-E1E2 antibodies, cirrhosis, triple therapy
- Medical subject headings
- Hepatitis C, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple therapyOther
Cohort of patients who received triple therapy combining pegylated-interferon/ribavirin + first generation protease inhibitor boceprevir or telaprevir as part of routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| HCV triple therapy | Cohort of HCV patients who received first-generation protease inhibitor-based triple therapy Receives: Other: Triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with positive anti-E1E2 antibody level at treatment initiation
Anti-E1E2 antibody levels were determined as previously described (Ndongo et al. Hepatology 2010;52:1531-42) using optical densities obtained after dilution of patients' serum samples at 1/250 and 1/500. Samples with anti-E1E2 levels above 950 (OD value× 1000) were considered positive.
Measured: Baseline (initiation of treatment)
Secondary outcomes (1)
Kinetic of Quantification of hepatitis C viral load (HCV RNA)
Viral load was assessed at baseline (initiation of treatment), and at week 4, 12, 24, 36, and 48 of therapy and 12 weeks after the end of treatment.
Measured: baseline (initiation of treatment), at week 4, 12, 24, 36, 48 of therapy, at 12 weeks after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJun 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877199
- Sponsor's protocol ID
- 69HCL16_0552
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 26 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-E1E2 Antibodies for the Prediction of Virological Response to Triple Therapy in Treatment-experienced Hepatitis C Virus-cirrhosis Cases
- ClinicalTrials.gov ID
- NCT02877199
- Acronym / sponsor ID
- 69HCL16_0552
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, anti-E1E2 antibodies, cirrhosis, triple therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Aug 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 hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV triple therapy | – | Other: Triple therapyCohort of HCV patients who received first-generation protease inhibitor-based triple therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatitis C virus infected patients with cirrhosis
Key inclusion criteria (4 listed)
- HCV patients with compensated cirrhosis (Child-Pugh A)
- HCV genotype 1
- non-responders to a previous course of interferon (IFN)/ribavirin
- receiving boceprevir or telaprevir
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Triple therapyCohort of patients who received triple therapy combining pegylated-interferon/ribavirin + first generation protease inhibitor boceprevir or telaprevir as part of routine clinical practice | Other | HCV triple therapy |
Primary outcome
Proportion of patients with positive anti-E1E2 antibody level at treatment initiation
Time frame: Baseline (initiation of treatment)
Anti-E1E2 antibody levels were determined as previously described (Ndongo et al. Hepatology 2010;52:1531-42) using optical densities obtained after dilution of patients' serum samples at 1/250 and 1/500. Samples with anti-E1E2 levels above 950 (OD value× 1000) were considered positive.
1 secondary outcome
Kinetic of Quantification of hepatitis C viral load (HCV RNA)
Time frame: baseline (initiation of treatment), at week 4, 12, 24, 36, 48 of therapy, at 12 weeks after the end of treatment.
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 26 Aug 2016.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 inclusion and 1 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 26 Aug 2016. 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?
Proportion of patients with positive anti-E1E2 antibody level at treatment initiation (time frame: Baseline (initiation of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2016.