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 Infection

Gilead Sciences313 sites in 1 country6,625 target enrollmentApril 13, 2012

ConditionsHepatitis C, Chronic

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hepatitis C, Chronic
Sponsor: Gilead Sciences
Enrollment: 6625
Locations: 313
Primary Endpoint: Proportion of participants maintaining SVR at Week 144 by treatment regimen
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.

Registry

clinicaltrials.gov

Start Date

April 13, 2012

End Date

January 8, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Gilead Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead oral antiviral agent (OAV)
•Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol
•Provide written, informed consent
•Be willing and able to comply with the visit schedule and protocol-mandated procedures

Exclusion Criteria

•Individuals planning 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 follow up, assessments, or compliance with the protocol
•Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Outcomes

Primary Outcomes

Proportion of participants maintaining SVR at Week 144 by treatment regimen

Time Frame: Week 144

Secondary Outcomes

Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen(Up to 144 weeks)
Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen(Up to 144 weeks)
Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen(Up to 144 weeks)
Liver disease progression(Up to 144 weeks)
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen(Up to 144 weeks)