Gilead Sustained Virologic Response (SVR) Registry

Trial ID or NCT#

NCT01457755

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Hepatologist, Transplant hepatologist
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health

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Contact

Mindie H. Nguyen, MD
650-498-7878