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A study to learn more about a combination of CFTR modulator medicines in people with Cystic Fibrosis

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

Open to recruitment

Participating Centres
Full title

A study to evaluate the effectiveness and safety of VX 445/Tezacaftor/Ivacaftor in people with Cystic Fibrosis who have two copies of the F508del gene

This study is being done to learn more about a new medication called ‘VX-445’ when taken in combination with tezacaftor and ivacaftor. All three of these medications are known as CFTR modulators. CFTR modulators work to treat the underlying genetic cause of cystic fibrosis. This combination of medication is being assessed in people with Cystic Fibrosis who are 12 years and older and who are homozygous for the F508del mutation. The study will investigate how well these medications work and to check that they are safe to use. It is the hope that this combination of medications will have positive effects in some people with Cystic Fibrosis. Participants will be asked to come into the clinic at the recruitment centre 7-8 times over a 5 month period where study assessments will take place (blood tests, questionnaires, lung function etc.).

Trial Reference Number

127111

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

CFTR Modulators

Last edited date

30 October 2019

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older
  • Homozygous for the F508del mutation
  • FEV1 value ≥40% and ≤90%
Top exclusion criteria
  • Clinically significant cirrhosis with or without portal hypertension.
  • Lung infection

CF centres running this trial

Recruiting

Alder Hey Children's Hospital

Address

Alder Hey Hospital Eaton Road West Derby Liverpool Merseyside L12 2AP

Recruitment ends

December 2019

Get in touch

Recruiting

Barts Health NHS Trust

Address

The Royal London Hospital, Whitechapel Road, London, Whitechapel E1 1BB

Recruitment ends

November 2019

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Recruiting

Bristol Royal Hospital for Children

Address

Upper Maudlin Street Bristol Avon BS2 8BJ

Recruitment starts

November 2019

Recruitment ends

December 2019

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Recruiting

Manchester University Hospitals NHS Foundation Trust

Address

Wythenshawe Hospital Southmoor Road, Wythenshawe, Manchester M23 9LT

Recruitment ends

December 2019

Contact

,

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Show all participating centres