A Gilead Sequence Registry of Subjects Who Did Not Achieve Sustained Virologic Response

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 Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01457768

Enrollment

570

Registered

2011-10-24

Start date

2011-12-19

Completion date

2018-04-09

Last updated

2018-05-04

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, Sequence, GS 5816, GS 7977, Sofosbuvir, Sovaldi™, SOF, Ledipasvir, LDV

Brief summary

This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.

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 OAV * Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol * Provide written, informed consent * Be willing and able to comply with the visit schedule 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 with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen	Up to 3 years

Secondary

Measure	Time frame	Description
Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen	Up to 3 years	—
Average number of DRM loss by treatment regimen	Up to 3 years	—
Liver disease progression	Up to 3 years	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, Canada, Czechia, Estonia, France, Germany, Italy, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Sweden, United Kingdom, United States

Outcome results