Details
Therapeutic categorythe type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise
Restore CFTR Function
Phasethe different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use
Phase III
Full title
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
This study will evaluate the long-term safety and tolerability of VX-659 in triple combination with Tezacaftor and Ivacaftor in subjects with cystic fibrosis (CF), including but not limited to those who are heterozygous for the F508del mutation
Trial Reference Number
108792
Trial type
Medication
Interventionthe name of the treatment or therapy being researched
CFTR Modulators
Recruitment targetthe number of participants who need to be recruited for the trial in the UK
460
Last edited date
11 July 2018
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial
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