NCT02877199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

10 months

First QC Date

August 12, 2016

Last Update Submit

August 25, 2016

Conditions

Hepatitis C

Keywords

Hepatitis Canti-E1E2 antibodiescirrhosistriple therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (initiation of treatment)

Secondary Outcomes (1)

  • 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.

Study Arms (1)

HCV triple therapy

Cohort of HCV patients who received first-generation protease inhibitor-based triple therapy

Other: Triple therapy

Interventions

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

HCV triple therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hepatitis C virus infected patients with cirrhosis

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, France

Location

MeSH Terms

Conditions

Hepatitis CFibrosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2016

First Posted

August 24, 2016

Study Start

June 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

FR(1)