Gilead Sustained Virologic Response (SVR) Registry
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
- Jacksonville, Florida: 14-001193
NCT ID: NCT01457755
Sponsor Protocol Number: GS-US-248-0122
About this study
This Registry is designed to provide long term clinical and virologic follow up in subjects who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored Hepatitis C Virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.
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:
- Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead oral antiviral agent (OAV)
- Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol
- Provide written, informed consent
- Be willing and able to comply with the visit schedule and protocol-mandated procedures.
Exclusion Criteria:
- Subject plans to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry.
- History of clinically-significant illness or any other major medical disorder that may interfere with subject 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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Surakit Pungpapong, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available