GS-9256 and GS-9190 in Patients with Hepatitis C Virus Infection.

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Open-Label Trial of GS 9256 plus GS 9190 alone and in Combination with Ribavirin for 28 Days in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS US 196 0112).

• IRAS ID

  38776

• Contact name

  Graham Foster

• Sponsor organisation

  Gilead Sciences, Inc

• Eudract number

  2009-013690-18

• ISRCTN Number

  Not Known

• Research summary

  This study is a Phase 2, Randomised, Open-Label, Trial of GS-9256 plus GS-9190 alone and in Combination with Ribavirin for 28 Days in Treatment Naive Subjects with Chronic Genotype 1 Hepatitis C Virus Infection. The purpose of this study is (1) to see if the study drug GS-9256 plus the study drug GS-9190 taken together with or without ribavirin (RIBA) are safe and well-tolerated in humans, (2) to assess the pharmacokinetics (measurement of the amount of study drug in the blood) of the study drugs in humans, and (3) to see whether this treatment can reduce the amount of the Hepatitis C virus (HCV) in the blood of humans. This study will recruit approximately 30 participants at about 15 study sites in the United Kingdom, France, Germany, and Belgium. Approximately 8 participants will be recruited in the UK. Participation in this study will last about 6 weeks, not including the screening visit. The participant will be required to visit the clinic at least 12 times. Participants will be randomised to receive one of 2 treatments: Arm 1 (approximately 15 participants): 75 mg GS-9256 plus 40 mg GS-9190 twice daily for 28 days; starting on Day 28, the participant will start standard of care with PEG/RIBA. Arm 2 (approximately 15 participants): 75 mg GS-9256 plus 40 mg GS-9190 twice daily plus RIBA for 28 days; starting on Day 28, the participant will start PEG and continue with PEG/RIBA as standard of care after. At the end of the study if the participant completes 28 days of treatment they will be offered the opportunity to participate in a separate follow-up registry study to evaluate if their HCV develops any resistance to the standard of care treatment.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  10/H0706/7

• Date of REC Opinion

  23 Feb 2010

• REC opinion

  Further Information Favourable Opinion