Gilead Sustained Virologic Response (SVR) Registry

Gilead Sciences

Status: Completed

Conditions: Hepatitis C, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01457755

2011-000945-19 (EudraCT Number)

GS-US-248-0122

Details and patient eligibility

About

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.

Enrollment: 6,625 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 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.