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

Chronic Hepatitis c Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03348059
• Other study ID #: CRC_GHN_2017_005
• Status: Completed
• Phase: N/A
• First received: November 16, 2017
• Last updated: November 16, 2017
• Start date: October 1, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: November 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 31, 2017
• Est. primary completion date: November 30, 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Direct-acting antiviral therapy
HCV patients received direct-acting antiviral treatment for 12 or 24 weeks

Locations

Country	Name	City	State
France	Croix-Rousse Hospital, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)