A long-term study to follow patients infected with chronic Hepatitis C who achieved a cure following treatment in a Gilead clinical trial

Phase 1

Conditions: Genotype 1 Hepatitis C Virus Infection
MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-000945-19-IT

Lead Sponsor: GILEAD SCIENCE INC.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 740

Inclusion Criteria

Willing and able to provide written informed consent; Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV; Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol; Be willing and able to comply with the visit schedule and protocol-mandated procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 666
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 74

Exclusion Criteria

Subject plans to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry. History of clinically-significant illness or any other major medical disorder that may interfere with subject follow-up, assessments or compliance with the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the durability of sustained virologic response (SVR) following treatment in a Gilead-sponsored Hepatitis C Study;Secondary Objective: To determine whether subsequent detection of HCV RNA in subjects who relapse following SVR, represents the re-emergence of pre-existing virus, the development of resistance mutations or whether it is due to re-infection; To assess clinical progression of liver disease; To screen for the development of hepatocellular carcinoma (HCC).;Primary end point(s): None. This is a registry study.;Timepoint(s) of evaluation of this end point: This observational registry will follow the patients for up to a maximum of three years.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None. This is an observational study.;Timepoint(s) of evaluation of this end point: Thi observational registry will follow the patients for up to a maximum of three years.