A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy (VX17-659-105)

Details

Therapeutic approach
Restore CFTR Function
Trial status
Study discontinued early Participating Centres
Trials Tracker ID
TT001951
Last updated
11/07/2018

Full title

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation

Study details

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation


Study results

This study assessed the long-term safety and tolerability of VX-659 triple combination therapy (VX-659/TEZ/IVA) in people with one or two copies of the F508del CFTR mutation.

A total of 484 people ages 12 and older enrolled onto the study.

Vertex made the decision to terminate study VX17-659-105 when the entire VX-659 programme was halted in favour of a more effective programme in the same patient population.


Phase
Phase 3
Recruitment target
460
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Age range
12 years and older
Including people

Completed study drug treatment or scheduled visits in a parent study

Age 12 Years and older

Homozygous or heterozygous for F508del

Excluding people

History of drug intolerance in a parent study

Current participation in an investigational drug trial (other than a parent study)

Get in touch

CF centres running this trial

Closed

Cambridge Royal Papworth Hospital (Adults)

CTAP centre
NHS Trust
Royal Papworth Hospital NHS Foundation Trust
Address
Papworth Road
CB2 0AY
Local site investigator
Charles Haworth
Trial Coordinators
Victoria Christenssen
Closed

Cardiff

CTAP centre
NHS Trust
Cardiff and Vale University Health Board
Local site investigator
Jamie Duckers
Trial Coordinators
Catherine Joyce
Closed

Leeds

CTAP centre
NHS Trust
The Leeds Teaching Hospitals NHS Trust
Address
St James's University Hospital
Beckett Street
LS9 7TF
Local site investigator
Daniel Peckham
Trial Coordinators
Neil Hall
Helen Chadwick
Closed

Liverpool Heart and Chest Hospital

NHS Trust
Liverpool Heart and Chest Hospital NHS Foundation Trust
Address
Thomas Drive
Liverpool
L14 3PE
Local site investigator
Martin Ledson
Closed

Manchester (Adults) - Wythenshawe Hospital

CTAP centre
NHS Trust
Manchester University NHS Foundation Trust
Address
Wythenshawe Hospital
South Moor Road
M23 9LT
Closed

Nottingham

CTAP centre
NHS Trust
Nottingham University Hospitals NHS Foundation Trust
Local site investigator
Helen Barr
Trial Coordinators
Fozia Naushahi
Christina Francis
Closed

Royal Brompton Hospital (London)

CTAP centre
NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Address
Royal Brompton Hospital
Sydney Street
SW3 6NP
Local site investigator
Nicholas Simmonds
Trial Coordinators
Mary Abkir