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A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (VX17-659-102)

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, Randomised, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

A Phase 3, Randomised, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Trial Reference Number

105982

Trial type

Medication

Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment

24 weeks

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

360

Last edited date

06 September 2018

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type

Commercial

Who can take part?

Mutation

One copy of F508del

Top inclusion criteria
  • Heterozygous for F508del and an minimal function mutation.
  • Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height.
Top exclusion criteria
  • Clinically significant cirrhosis with or without portal hypertension.
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Lung infection with organisms associated with a more rapid decline in pulmonary status.

CF centres running this trial

Closed

Cardiff & Vale UHB R&D Office - Secondary Care

Address

Cardiff and Vale UHB R&D Office 2nd Floor TB2 University Hospital of Wales Heath Park Cardiff CF14 4XW

Recruitment ends

May 2019

Contact

Duckers, Jamie

Get in touch

Closed

Leeds Teaching Hospitals NHS Trust

Address

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

Recruitment starts

May 2018

Recruitment ends

July 2018

Contact

Peckham, Daniel

Get in touch

Closed

Liverpool Heart and Chest Hospital

Address

Thomas Drive Liverpool Merseyside L14 3PE

Recruitment starts

April 2018

Recruitment ends

August 2018

Contact

Ledson, Martin

Get in touch

Closed

Nottingham University Hospitals NHS Trust

Address

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

Recruitment starts

May 2018

Recruitment ends

July 2018

Contact

Barr, Helen

Get in touch
Show all participating centres