A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infectio

Phase 2

Completed

Conditions: Hepatitis C infection
liver disease
10019654
10047438

Registration Number: NL-OMON41568

Lead Sponsor: Gilead Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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 oral antiviral agent (OAV);
3. Have achieved Sustained Virologic Response 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.

Exclusion Criteria

Subjects who meet any of the following exclusion criteria are not to be enrolled in this Registry:
1. Subject plans to start a new course of hepatitis C therapy including any investigational drug or medical 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: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoints are:<br /><br>• The proportion of subjects maintaining SVR at Week 144 per treatment regimen. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are:<br /><br>• The proportion of subjects with detectable HCV RNA due to re-emergence of<br /><br>pre-existing virus through Week 144 per treatment regimen;<br /><br>• The proportion of subjects with detectable HCV resistance mutations through<br /><br>Week 144 per treatment regimen;<br /><br>• The proportion of subjects with detectable HCV RNA due to re-infection<br /><br>through Week 144 per treatment regimen;<br /><br>• Liver Disease progression, as assessed by clinical and laboratory parameters;<br /><br>• The proportion of subjects who develop HCC through Week 144 per treatment<br /><br>regimen.<br /><br><br /><br>Other endpoints of interest are:<br /><br>• Route of re-infection, if known.</p><br>