Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

This Registry will enroll cirrhotic participants with or without decompensated liver disease who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir (SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants will be followed for up to 5 years.

Official Title

A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

Keywords

Hepatitis C Virus InfectionHCV Cirrhosis registryCirrhosisHepatitis CInfectionCommunicable DiseasesHepatitisHepatitis AHepatitis, ChronicFibrosisLiver CirrhosisHepatitis C, ChronicVirus DiseasesInterferonsSofosbuvir

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Have either previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have received an all-oral SOF-based regimen outside a clinical study. These individuals must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12.
  • Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment.
  • Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen OR individuals who enroll after receiving an all-oral SOF-based regimen outside a clinical study, will have had cirrhosis confirmed prior to initiation of HCV treatment.

Key Exclusion Criteria:

  • Individuals planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
  • History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • University of California at San Francisco Medical Center
    San FranciscoCaliforniaUnited States
  • Quest Clinical Research
    San FranciscoCaliforniaUnited States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT02292706
Study Type
Observational [Patient Registry]
Last Updated