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VX18-121-101 Safety and Efficacy of VX-121 combination therapy 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

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 II

Full title

A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis

The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121 combination therapy in subjects with cystic fibrosis.

Trial Reference Number

113399

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

CFTR Modulators in combination

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

90

Last edited date

28 January 2019

CF sponsor

Vertex Pharmaceuticals Incorporated

CF sponsor type

Commercial

Who can take part?

Age

18+

Top inclusion criteria
  • Part 1: Heterozygous for F508del and an MF mutation
  • Part 2: Homozygous for F508del
  • FEV1 value ≥40% and ≤90% of the predicted mean for age, sex, and height
Top exclusion criteria
  • History of clinically significant cirrhosis with or without portal hypertension.
  • Lung infection with organisms associated with a more rapid decline in pulmonary status.

CF centres running this trial

Closed

Heartlands Hospital

Address

Bordesley Green East Birmingham B9 5SS

Recruitment starts

June 2019

Recruitment ends

August 2019

Contact

Nash, Edward

Get in touch

Closed

Royal Brompton Hospital

Address

Sydney Street London SW3 6NP

Recruitment starts

May 2019

Recruitment ends

August 2019

Contact

Davies, Jane C

Get in touch

Closed

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Address

Freeman Hospital Freeman Road High Heaton Newcastle upon Tyne NE7 7DN

Contact

,

Get in touch

Closed

University Hospital Llandough

Address

Penlan Road, Llandough, Penarth, South Glamorgan CF64 2XX

Recruitment ends

July 2019

Contact

Duckers, Jamie

Get in touch
Show all participating centres