Gilead HCV Registry 0122 - Responders
Research type
Research Study
Full title
A Long Term Follow-up Registry Study of Subjects Who Achieve Sustained Virologic Response in Gilead Sponsored Trials in Subjects with Chronic Hepatitis C Infection
IRAS ID
88437
Contact name
Mark R Thursz
Sponsor organisation
Gilead Sciences Inc.
Eudract number
2011-000945-19
ISRCTN Number
NO ACTION
Research summary
The research is a long-term study to follow patients infected with chronic Hepatitis C who achieve a cure following treatment in a previous Gilead clinical trial. Clinic visits will occur at Baseline and at Weeks 24, 48, 72, 96, 120 and 144. At each visit, subjects will have blood drawn for plasma assessments to check for virus RNA, viral sequencing, liver function, and specific blood parameters. Viral sequences to be evaluated will be based on the specific antiviral agent(s) that the subject was treated with during the initial Gilead-sponsored treatment protocol. Subjects who have no drug resistant mutations (DRMs) by a sensitive sequencing method at any time during the Registry and subjects who begin a new treatment course for HCV infection will discontinue participation in the Registry. This observational Registry will follow subjects for up to three years. Adverse events determined to be related to a study procedure occurring during the course of this Registry study will be followed and documented in accordance with this protocol. No test product will be administered in this Registry.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
11/LO/1455
Date of REC Opinion
19 Dec 2011
REC opinion
Further Information Favourable Opinion