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Summary

Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

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

Keywords

Hepatitis C, Chronic 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 Sovaldiā„¢ SOF Ledipasvir LDV

Eligibility

For people ages 18 years and up

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.

Locations

  • California Pacific Medical Center
    San Francisco, California, 94115, United States
  • Quest Clinical Research
    San Francisco, California, 94115, United States
  • Stanford University
    Palo Alto, California, 94304, United States
  • Silicon Valley Research Institute
    San Jose, California, United States
  • San Jose Gastroenterology
    San Jose, California, 95116, United States
  • UC Davis Medical Center
    Davis, California, 95616, United States
  • UC Davis Medical Center
    Sacramento, California, 95817, United States
  • Franco Felizarta, MD
    Bakersfield, California, 93301, United States
  • Kaiser Permanente of Colorado
    Los Angeles, California, 90027, United States
  • 8631 West 3rd Street
    Los Angeles, California, 90048, United States
  • California Liver Institute
    Los Angeles, California, 90048, United States
  • Peter J. Ruane, MD, Inc.
    Los Angeles, California, 90036, United States
  • 660 South Fair Oaks Avenue
    Pasadena, California, 91105, United States
  • Anthony Mills MD, Inc
    Los Angeles, California, United States
  • Cedars-Sinai Medical Center
    Los Angeles, California, United States
  • Veterans Administration Wadsworth Medical Center
    Los Angeles, California, United States
  • Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
    Torrance, California, United States
  • Los Angeles BioMedical Institute at Harbor-UCLA Medical Center
    Torrance, California, 90502, United States
  • VA Long Beach Healthcare System
    Long Beach, California, 90822, United States
  • Advanced Clinical Research Institute, LLC
    Anaheim, California, 92801, United States
  • West Coast Clinical Trials, LLC
    Costa Mesa, California, 92626, United States
  • Impact Clinical Trials
    Las Vegas, Nevada, 89106, United States
  • eStudySite
    Oceanside, California, 92056, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT01457768
Study Type
Observational
Last Updated
May 1, 2017