Gilead Sustained Virologic Response (SVR) Registry

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT01457755
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-24
• Study Start: 2012-04-13
• Primary Completion: 2017-03-28
• Study Completion: 2018-01-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6625

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

Key

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants maintaining SVR at Week 144 by treatment regimen	Week 144

Secondary Outcome Measures

Name	Time	Method
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	Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen	Up to 144 weeks

Trial Locations

Locations (313)

Birmingham Gastroenterology Associates; 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Digestive Health Specialists of the Southeast, PA; 🇺🇸 Dothan, Alabama, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

The University of Arizona; 🇺🇸 Tucson, Arizona, United States

Advanced Clinical Research Institute, LLC; 🇺🇸 Anaheim, California, United States

Franco Felizarta, MD; 🇺🇸 Bakersfield, California, United States

Southern California Liver Centers; 🇺🇸 Coronado, California, United States

West Coast Clinical Trials, LLC; 🇺🇸 Costa Mesa, California, United States

Scripps Clinic Medical Group; 🇺🇸 La Jolla, California, United States

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