A rollover study of VX-770 in Subjects with Cystic Fibrosis

• Research type

  Research Study

• Full title

  An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis

• IRAS ID

  53575

• Contact name

  Stuart Elborn

• Sponsor organisation

  Vertex Pharmaceuticals Incorporated

• Eudract number

  2009-012997-11

• Research summary

  Vertex Pharmaceuticals Incorporated, is developing a drug called VX-770 as a possible treatment for Cystic Fibrosis (CF). VX-770 is an experimental drug, which means that it has not been approved for prescribing to people. VX-770 is being studied to see if it can help decrease some of the effects caused by CF. This study is also being done to learn more about the safety and effects of long term treatment with VX-770 on CF patients. This study is a follow on study for patients who have already taken part in previous studies on VX-770. It is being done at 70 CF treatment centres in North America, Europe and Australia. All subjects taking part in the study will take a dose of VX-770 twice a day by mouth.After initial study visits at day 1 and day 15, each subject will attend the clinic for a visit every 3 months. The study is for 96 weeks, or less if VX-770 becomes available by prescription in this country before that.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  10/S0501/33

• Date of REC Opinion

  8 Jul 2010

• REC opinion

  Further Information Favourable Opinion