Summary

for people ages 18 years and up (full criteria)
at La Jolla, 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 Infection HCV Cirrhosis registry Cirrhosis Hepatitis C Infection Communicable Diseases Hepatitis Hepatitis A Hepatitis, Chronic Fibrosis Liver Cirrhosis Hepatitis C, Chronic Virus Diseases Interferons Sofosbuvir

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 San Diego (UCSD)
    La Jolla California United States
  • University of California San Diego Medical Center
    San Diego California United States
  • Scripps Clinic Medical Group
    La Jolla California United States
  • Kaiser Permanente
    San Diego California United States
  • Medical Associates Research Group
    San Diego California United States
  • Southern California Medical Group
    Coronado California United 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
June 8, 2018