Gilead Sustained Virologic Response (SVR) Registry

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01457755

Enrollment

6625

Registered

2011-10-24

Start date

2012-04-13

Completion date

2018-01-08

Last updated

2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Tegobuvir, Registry, HCV RNA, Treatment experienced, Treatment naive, GS 9451, GS 5885, GS 7977, GS 5816, Sofosbuvir, Sovaldi™, SOF, Ledipasvir, LDV

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key 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/

Design outcomes

Primary

Measure	Time frame
Proportion of participants maintaining SVR at Week 144 by treatment regimen	Week 144

Secondary

Measure	Time frame	Description
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	—

Countries

Australia, Austria, Belgium, Canada, Czechia, Estonia, France, Germany, Italy, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Sweden, United Kingdom, United States

Outcome results