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 (VX17-445-105)

Details

Therapeutic approach
Restore CFTR Function
Trial status
Recruitment complete Participating Centres
Trials Tracker ID
TT001956
Last updated
07/02/2020

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

Study details

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


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)

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CF centres running this trial

Closed

Belfast

CTAP centre
NHS Trust
Belfast Health & Social Care Trust
Local site investigator
Damian Downey
Trial Coordinators
Catherine McNeill
Closed

Birmingham Heartlands Hospital (Adults)

CTAP centre
NHS Trust
University Hospitals Birmingham NHS Foundation Trust
Address
Bordesley Green
B9 5SS
Local site investigator
Joanna Whitehouse
Trial Coordinators
Aoife Neal
Closed

Edinburgh - Western General Hospital (Adults)

CTAP centre
NHS Trust
NHS Lothian
Address
Crewe Road South
EH4 2XU
Trial Coordinators
Ellyse Kilarski
Closed

King's College Hospital (London)

CTAP centre
NHS Trust
King's College Hospital NHS Foundation Trust
Address
King's College Hospital
Denmark Hill
SE5 9RS
Local site investigator
Patricia Macedo
Trial Coordinators
Mélanie Le Sayec
Closed

Leeds Children's Hospital

CTAP centre
NHS Trust
The Leeds Teaching Hospitals NHS Trust
Address
Clarendon Wing
Belmont Grove
LS2 9NS
Local site investigator
Tim Lee
Trial Coordinators
Yasmin Khanagha
Closed

Manchester (Adults) - Wythenshawe Hospital

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

Royal Devon & Exeter Hospital

CTAP centre
NHS Trust
The Royal Devon & Exeter NHS Foundation Trust
Address
Barrack Road
EX2 5DW
Local site investigator
Nick Withers
Trial Coordinators
Sophie Whiteley
Closed

Southampton General Hospital

CTAP centre
NHS Trust
University Hospital Southampton NHS Foundation Trust
Address
Tremona Road
SO16 6YD
Local site investigator
Julian Legg
Trial Coordinators
Matthew Harvey