Anti-E1E2 (D32.10 Epitope-binding) Antibodies Status Prio... | NCT03348059

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

NCT03348059

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Nov 20, 2017Actual

Enrollment

103Actual

Phase

Not provided

Conditions

Chronic Hepatitis c

Interventions

Direct-acting antiviral therapy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

Nov 30, 2016Actual

Completion Date

Mar 31, 2017Actual

First Submitted Date

Nov 16, 2017

First Submission Date that Met QC Criteria

Nov 16, 2017

First Posted Date

Nov 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2017

Last Update Posted Date

Nov 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Direct-acting antiviral therapy	Drug	HCV patients received direct-acting antiviral treatment for 12 or 24 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Croix-Rousse Hospital, Hospices Civils de Lyon		Lyon		69004	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided