A Study of CFTR modulator combination therapy for people Heterozygous for the F508del Mutation and a Minimal Function Mutation (VX-659)

Details

Therapeutic approach
Restore CFTR Function
Trial status
Closed with results Participating Centres
Trials Tracker ID
TT001861
Last updated
17/10/2019

Full title

A Phase 3, Randomised, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Study details

A Phase 3, Randomised, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)


Phase
Phase 3
Length of participation
24 weeks
Recruitment target
360
CF sponsor
Vertex Pharmaceuticals Incorporated
CF sponsor type
Commercial

Who can take part?

Age range
12 years and older
Including people

Age 12 years or older
Heterozygous for F508del and a minimal function mutation
FEV1 value ≥40% and ≤90% of predicted mean for age, sex, and height

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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
Deepa George
Victoria Christenssen
Closed

Cardiff - University Hospital Llandough (Adults)

CTAP centre
NHS Trust
Cardiff and Vale University Health Board
Address
Penland Road
Llandough
CF64 2XX
Local site investigator
Jamie Duckers
Trial Coordinators
Catherine Joyce
Closed

Glasgow - Queen Elizabeth University Hospital

CTAP centre
NHS Trust
NHS Greater Glasgow & Clyde
Address
1345 Govan Road
G51 4TF
Local site investigator
Gordon MacGregor
Trial Coordinators
Annie Husband
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
Yasmin Khanagha
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
Local site investigator
Andy Jones
Trial Coordinators
Sarah Sampson
Closed

Nottingham

CTAP centre
NHS Trust
Nottingham University Hospitals NHS Foundation Trust
Local site investigator
Helen Barr
Trial Coordinators
Fozia Naushahi
Gillian Black
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
Sophie Pinnell
Closed

Royal Manchester Children's Hospital (Paediatrics)

CTAP centre
NHS Trust
Manchester University NHS Foundation Trust
Address
Oxford Road
M13 9WL
Local site investigator
Anirban Maitra
Trial Coordinators
Sarah Sampson