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

Completed

• Conditions: Hepatitis C
• Interventions: Other: Triple therapy

• Registration Number: NCT02877199
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-08
• Study First Submitted: 2016-08-12
• Study First Submitted QC: 2016-08-23
• Study First Posted: 2016-08-24
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCV triple therapy	Triple therapy	Cohort of HCV patients who received first-generation protease inhibitor-based triple therapy

Primary Outcome Measures

Name	Time	Method
Proportion of patients with positive anti-E1E2 antibody level at treatment initiation	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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France