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

Not Recruiting

Trial ID: NCT01457768

Purpose

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.

Official Title

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

Stanford Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD

Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

Eligibility


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.

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H. Nguyen, MD
650-498-7878