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

Conditions: Genotype 1 Hepatitis C Virus Infection
MedDRA version: 14.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-000945-19-HU

Lead Sponsor: Gilead Sciences Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 740

Inclusion Criteria

1. Willing and able to provide written informed consent;
2. Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV;
3. Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol;
4. 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

1. 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.
2. 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;Primary end point(s): None. This is an observational study.;Timepoint(s) of evaluation of this end point: n/a;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;<br><br>To assess clinical progression of liver disease;<br><br>To screen for the development of hepatocellular carcinoma (HCC).<br>

Secondary Outcome Measures