C219 HCV roll-over trial of telaprevir from VX-950-TiDP24 control grp

• Research type

  Research Study

• Full title

  An open-label, single-arm, roll-over trial of telaprevir in combination with pegylated interferon alfa-2a (Pegasys®) and ribavirin (Copegus®) for subjects from the control group of the VX-950-TiDP24-C216 trial who failed therapy for virologic reasons

• IRAS ID

  37394

• Contact name

  Graham R Foster

• Sponsor organisation

  GCO (division of Janssen-Cilag Ltd)

• Eudract number

  2009-012613-21

• ISRCTN Number

  n/a

• Research summary

  This study is continuation trial for subjects who were randomised to the control group in an earlier Telaprevir study (the C216 trial) receiving standard treatment of Peg-interferon (Peg-IFN) and Ribavarin (RBV) and who failed treatment (i.e. virus remained in their blood despite treatment). The aim of this trial is to provide these subjects with early access to a Telaprevir containing treatment. The effectiveness, safety, and tolerability of Telaprevir in combination with Peg-IFN and RBV will be evaluated. The trial will consist of a screening period of approximately 28 days, a 48-week treatment period (during which all subjects will receive 12 weeks of Telaprevir in combination with Peg-IFN and RBV at standard doses, followed by 36 weeks of Peg-IFN and RBV at standard doses), and a 24-week follow-up period. All subjects will attend a Safety Follow-up Visit 4 weeks after the last dose of study medication.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  10/H0405/9

• Date of REC Opinion

  23 Feb 2010

• REC opinion

  Further Information Favourable Opinion