A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects with Chronic Hepatitis C Infection (Protocol #: GS-US-248-0122: 13 April 2011)

Study ID
STU 102011-094

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other

Contact
Theresa Hardwick
214-645-6195
theresa.hardwick@utsouthwestern.edu

Principal Investigator
William Lee

Summary

This Registry will enroll subjects who have achieved an SVR after receiving at least one oral antiviral agent (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. Visits will occur at Baseline and then at Weeks 24, 48, 72, 96, 120 and 144. at each visit, subjects will have blood drawn for plasma HCV Rna quantification, liver function tests, platelets, coagulation test and [RegisteredTM]-fetoprotein. if HCV Rna is detected, the subject will have a repeat blood sample drawn for confirmation. if HCV Rna is confirmed the subject will be withdrawn from the Registry. if the confirmed HCV Rna is [Greater Than] LLoQ, viral sequence analysis will be performed.a quality of life questionnaire will be done at each visit to add to the understandinng of changes in the quality of life in subjects who have achieved a sustained virological response from the initial Gilead-sponsored teatment protocol.

This study is open to any subject who has achieved an SVR after receiving at least one Gilead oaV while participating in a Gilead sponsored hepatitis C study. The total number of people participating in this research study at over 100 centers in the united States and world-wide is unknown. about 30 patients who attain SVR will be enrolled in this study at uT Southwestern Medical Center.

Participant Eligibility

Subjects must meet all of the following inclusion criteria to be eligible for participation in this Registry.
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 achieved SVR in a 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.