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A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy (VX17-445-105)

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
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-445 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-445 in triple combination withT ezacaftor (TEZ) and Ivacaftor (IVA) in subjects with cystic fibrosis who are homozygous or heterozygous for the F508del mutation..

Trial Reference Number

109563

Trial type

Medication

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

460

Last edited date

08 November 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 older
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

Recruiting

Heart of England NHS Foundation Trust

Address

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

Recruitment starts

December 2018

Recruitment ends

June 2019

Contact

Nash, Edward

Get in touch

Recruiting

Leeds Teaching Hospitals NHS Trust

Address

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

Recruitment starts

December 2018

Recruitment ends

July 2019

Contact

Lee, Timothy

Get in touch

Closed

Southampton General Hospital

Address

Tremona Road Southampton Hampshire SO16 6YD

Recruitment starts

December 2018

Recruitment ends

December 2018

Contact

Legg, Julian

Get in touch