NCT02877199CompletedNot Applicable
Anti-E1E2 Antibodies for the Prediction of Virological Response to Triple Therapy in Treatment-experienced Hepatitis C Virus-cirrhosis Cases
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Proportion of patients with positive anti-E1E2 antibody level at treatment initiation
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Kinetic of Quantification of hepatitis C viral load (HCV RNA)(baseline (initiation of treatment), at week 4, 12, 24, 36, 48 of therapy, at 12 weeks after the end of treatment.)
Investigators
Study Sites (1)
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