GS-US-248-0123: A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection

Study ID
STU 102012-074

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Michael Thomas
214-590-5717
michael.thomas@utsouthwestern.edu

Principal Investigator
Mamta Jain

Summary

This Registry will enroll subjects who did not achieve an SVR after receiving at least one oaV while participating in a Gilead-sponsored hepatitis C clinical trial. The definition of an SVR is defined in the initial Gilead-sponsored treatment protocol.

once enrolled, subjects will be followed for up to 3 years. a Baseline visit will be scheduled within 90 days from the last visit in the Gilead-sponsored treatment protocol. Subsequent visits will occur at Weeks 24, 48, 72, 96, 120 and 144. at each visit, subjects will have a blood sample collected for HCV Rna, viral sequencing, liver function tests, platelets, coagulation test and [RegisteredTM]-fetoprotein. in addition, a quality of life survey will be completed at each visit.

Participant Eligibility

1. Willing and able to provide written informed consent;

2. Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead OAV;

3. Have failed to achieve an SVR in that previous Gilead-sponsored study, as defined in the original treatment protocol;

4. Be willing and able to comply with the visit schedule and protocol-mandated procedures.