Status:
TERMINATED
A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepato...
Eligibility Criteria
Inclusion
- Key
- 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 \< lower limit of quantification (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
- 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.
Key Trial Info
Start Date :
December 29 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
1609 Patients enrolled
Trial Details
Trial ID
NCT02292706
Start Date
December 29 2014
End Date
December 31 2021
Last Update
October 4 2023
Active Locations (138)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States
2
Scripps Clinic Medical Group
La Jolla, California, United States
3
V.A. Long Beach Medical Center
Long Beach, California, United States
4
Cedars Sinai Medical Center
Los Angeles, California, United States