Gilead HCV Registry 0123 - Non-Responders

• Research type

  Research Study

• Full title

  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

• IRAS ID

  86738

• Contact name

  Mark R Thursz

• Sponsor organisation

  Gilead Sciences Inc.

• Eudract number

  2011-000946-39

• ISRCTN Number

  NO ISSUE

• Research summary

  The research is a long-term study to follow patients infected with chronic Hepatitis C who did not achieve a cure following treatment in a previous Gilead clinical trial. Clinic visits will occur at Baseline and at Weeks 12, 24, 36, 48, 96 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/1456

• Date of REC Opinion

  19 Dec 2011

• REC opinion

  Further Information Favourable Opinion