A Registry for Cirrhosis that has a Sustained Virologic Response Following Sofosbuvir-Based Treatment without Interferon, for Patients who have 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
- Rochester, Minnesota: 15-009337
NCT ID: NCT02292706
Sponsor Protocol Number: GS-US-337-1431
About this study
The purpose of this registry is to enroll patients who have cirrhosis with a sustained viral response after receiving a sofosbuvir-based treatment without interferon, either while participating in a Gilead-sponsored hepatitis C virus study or commercially at selected sites. Once enrolled, the patients 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
- Has either previously participated in a Gilead-sponsored HCV study (or at pre-selected sites only) and received
- A sofosbuvir-containing regimen without interferon
- Must achieve SVR as defined in the treatment protocol
- Has liver cirrhosis, as defined in the treatment protocol
- Has not had a liver transplant after receiving a SOF-containing regimen
- An all-oral SOF-based regimen (outside a clinical study)
- Must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12
- SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment
- Will have had cirrhosis confirmed prior to initiation of HCV treatment
Exclusion Criteria
- 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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Kymberly Watt, 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