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VX17-659-105 Open-label Safety and Efficacy of VX-659 in CF

Details

Therapeutic category
the 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

Trial status

Closed to recruitment - in follow up

Participating Centres
Phase
the 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

Intervention
the name of the treatment or therapy being researched

CFTR Modulators

Recruitment target
the 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

Who can take part?

Top inclusion criteria
  • Completed study drug treatment in a parent study; or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.
  • 12 years and above
Top exclusion criteria
  • History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
  • Current participation in an investigational drug trial (other than a parent study).

CF centres running this trial

Closed

Leeds Teaching Hospitals NHS Trust

Address

St. James's University Hospital Beckett Street Leeds West Yorkshire LS9 7TF

Recruitment starts

November 2018

Recruitment ends

January 2019

Contact

Peckham, Daniel

Get in touch

Closed

Liverpool Heart and Chest Hospital

Address

Thomas Drive Liverpool Merseyside L14 3PE

Recruitment starts

August 2018

Recruitment ends

January 2019

Contact

Ledson, Martin

Get in touch

Closed

Nottingham University Hospitals NHS Trust

Address

Trust Headquarters City Hospital campus Hucknall Road Nottingham Nottinghamshire NG7 2UH

Contact

Barr, Helen

Get in touch

Closed

Royal Brompton Hospital

Address

Sydney Street London SW3 6NP

Recruitment starts

August 2018

Recruitment ends

January 2019

Contact

Simmonds, Nicholas

Get in touch