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

Gilead Sciences

Status: Completed

Conditions: Hepatitis C, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01457768

2011-000946-39 (EudraCT Number)

GS-US-248-0123

Details and patient eligibility

About

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.

Enrollment: 570 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/Exclusion criteria may apply.