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A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation

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, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation.

Trial Reference Number

108763

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

Tezacaftor, Ivacaftor, VX445

Recruitment target
the number of participants who need to be recruited for the trial in the UK

360

Last edited date

27 June 2019

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type

Commercial

Who can take part?

Mutation

One copy of F508del

Top inclusion criteria
  • FEV1 above or equal to 40% and below or equal to 90%
  • 12 Years and older
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

Central Manchester University Hospitals NHS Foundation Trust

Address

Trust Headquarters Cobbett House Manchester Royal Infirmary Oxford Road Manchester Greater Manchester M13 9WL

Recruitment ends

July 2018

Contact

,

Get in touch

Closed

Heart of England NHS Foundation Trust

Address

Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

October 2018

Recruitment ends

June 2019

Contact

Nash, Edward

Get in touch

Closed

King's College Hospital NHS Foundation Trust

Address

Denmark Hill London Greater London SE5 9RS

Recruitment starts

September 2018

Recruitment ends

October 2018

Contact

Macedo, Patricia

Get in touch

Closed

Leeds Teaching Hospitals NHS Trust

Address

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

Recruitment starts

September 2018

Recruitment ends

October 2018

Contact

Lee, Timothy

Get in touch
Show all participating centres