NCT03348059

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

November 16, 2017

Last Update Submit

November 16, 2017

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (1)

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

    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

    Baseline (treatment initiation day)

Interventions

Direct-acting antiviral therapyDRUG

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

Eligibility Criteria

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

Hepatitis C virus (HCV)-infected patients treated with direct-acting antiviral treatment

You may qualify if:

  • 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

You may not qualify if:

  • HIV or hepatitis B virus (HBV) coinfection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Croix-Rousse Hospital, Hospices Civils de Lyon

Lyon, 69004, France

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic 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

November 16, 2017

First Posted

November 20, 2017

Study Start

October 1, 2015

Primary Completion

November 30, 2016

Study Completion

March 31, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)