A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response 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-OMON41602

Lead Sponsor: Gilead Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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;
3 Have failed to achieve an SVR in a previous 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 is currently receiving or 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 with at least one DRM loss from Enrollment to End<br /><br>of Study by treatment regimen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are:<br /><br>• Proportion of subjects with DRM loss by unit category, 1, 2, 3,*n, by<br /><br>treatment regimen;<br /><br>• Average number of DRM loss by 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 by treatment<br /><br>regimen.</p><br>