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OpenTrials
Completed

NCT Number: NCT03348059

Anti-E1E2 (D32.10 Epitope-binding) Antibodies Status Prior Therapy Favors Direct-acting Antiviral Treatment Efficacy

The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in Hepatitis C virus (HCV)-infected patients receiving direct-acting antiviral treatment

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Key information

About this study

Presence of anti-E1E2 antibodies was previously associated with spontaneous cure of hepatitis C virus (HCV). The hypothesis was to check whether baseline anti-E1E2 antibodies could predict virological outcome in HCV-infected patients receiving direct-acting antiviral treatment

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • HCV patients treated with direct-acting antiviral treatment
  • Patients with a prior treatment blood sample
  • Patients with sustained virological response or virological relapse

Exclusion criteria

  • HIV or hepatitis B virus (HBV) coinfection

Treatment and study plan

Direct-acting antiviral therapy

Drug

HCV patients received direct-acting antiviral treatment for 12 or 24 weeks

Primary outcomes

  1. Proportion of patients with positive anti-E1E2 antibody level at treatment initiation

    Time frame: Baseline (treatment initiation day)

    Anti-E1E2 antibody levels were determined 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 20, 2017
Registry last updated
Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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