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Anti-E1E2 Antibodies (D32.10 Epitope-binding Antibodies) and HCV Triple Therapy

Anti-E1E2 Antibodies for the Prediction of Virological Response to Triple Therapy in Treatment-experienced Hepatitis C Virus-cirrhosis Cases

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02877199
Enrollment
19
Registered
2016-08-24
Start date
2014-06-30
Completion date
2015-04-30
Last updated
2016-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C, anti-E1E2 antibodies, cirrhosis, triple therapy

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.

Interventions

Cohort of patients who received triple therapy combining pegylated-interferon/ribavirin + first generation protease inhibitor boceprevir or telaprevir as part of routine clinical practice

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

\-

Design outcomes

Primary

MeasureTime frameDescription
Proportion of patients with positive anti-E1E2 antibody level at treatment initiationBaseline (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

MeasureTime frameDescription
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.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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026