TMC435-TiDP16-C213

• Research type

  Research Study

• Full title

  A Phase III open label trial of TMC435 in combination with peginterferon alfa-2a and ribavirin for HCV genotype-1 infected subjects who participated in the placebo group of a Phase II/III TMC435 study (C201, C205, C206, C208, C216 or HPC3007), or who received short-term (up to 14 days) direct-acting antiviral treatment for hepatitis C infection in a selected Tibotec sponsored Phase I study.

• IRAS ID

  83363

• Contact name

  Graham Foster

• Sponsor organisation

  Tibotec Pharmaceuticals

• Eudract number

  2011-000416-25

• ISRCTN Number

  N/A

• Research summary

  Treatment options for Hepatitis C are limited. The current Standard of Care for treatment is a combination of two drugs - peglated interferon (PegIFN.-2a ) and ribavirin (RBV). TMC435 is in the process of development for the treatment of subjects with chronic Hepatitis C and the data that will be drawn from this study will be of scientific value in addressing the efficiacy of the medication in a well characterised group of patients, as well as ascertaining the safety profile and viral response rates in this group of patients. This is an open label study of TMC435 in combination with PegIFN and RBV.The study will provide access for treatment to subjects who have previously taken part in a TMC435 study and were allocated to take a 'placebo' rather than TMC435 or subjects who have previously taken a short-term dose of Antiviral treatment for treating Hepatitis C infection in a selected Tibotec Sponsored Phase I study. Approximately 270 HCV genotype-1 infected subjects who participated in the placebo group of a Phase II/III. TMC435 study are expected to be enrolled in this study. In addition, HCV genotype-1 infected subjects who received short-term (up to 14 days) DAA treatment for HCV infection in a selected Tibotec-sponsored Phase I study will also be allowed to enter this study. All subjects will receive TMC435 150 mg once daily (q.d.) in combination with PegIFN/RBV for 12 weeks. A response-guided 24-or 48-week total treatment duration.For all subjects, there will be a post-therapy follow-up period of 24 weeks after the planned end of treatment.The total study duration (from screening till final study visit) for any given subject will be a maximum of 78 weeks, including a screening period up to 6 weeks. The study is considered completed with the last visit of the last subject participating in the study.

• REC name

  London - South East Research Ethics Committee

• REC reference

  11/LO/1220

• Date of REC Opinion

  15 Nov 2011

• REC opinion

  Further Information Favourable Opinion