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
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 15-002393
NCT ID: NCT02292706
Sponsor Protocol Number: GS-US-337-1431
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 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 will have had cirrhosis confirmed prior to initiation of HCV treatment
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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Hugo Vargas, M.D. |
Closed for enrollment |
|
More information
Publications
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Hepatocellular carcinoma (HCC) is the leading cause of death in patients with chronic hepatitis. In this international collaboration, we sought to develop a global universal HCC risk score to predict the HCC development for patients with chronic hepatitis.
Read More on PubMed