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A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VX-445
TEZ
IVA
IVA
Sponsored by
Vertex Pharmaceuticals Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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)

Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Banner University of Arizona Medical Center
  • University of Arkansas for Medical Sciences
  • Miller Children's Hospital / Long Beach Memorial
  • Children's Hospital Los Angeles
  • Valley Children's Hospital
  • Kaiser Permanente
  • University of California Davis Medical Center
  • UCSF Gateway Medical Center
  • National Jewish Health
  • University of Florida, Shands Hospital
  • Joe DiMaggio Cystic Fibrosis & Pulmonary Center
  • Nemours Children's Specialty Care
  • Central Florida Pulmonary Group, PA
  • Nemours Children's Hospital
  • Tampa General Hospital Cardiac and Lung Transplant Clinic
  • Children's Specialty Services at North Druid Hills
  • Augusta University
  • Ann & Robert Lurie Children's Hospital of Chicago
  • Northwestern Memorial Hospital
  • Cystic Fibrosis Center, Children's Hospital of Illinois at OSF Saint Francis Medical Center
  • The University of Kansas Medical Center
  • Tulane Medical Center
  • Maine Medical Partners
  • Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center
  • Harper University Hospital
  • Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
  • Billings Clinic Hospital
  • Nebraska Medical Center
  • Morristown Medical Center
  • UNM Clinical and Translational Science Center
  • The Cystic Fibrosis Center, Mount Sinai Beth Israel
  • New York Medical College
  • UNC Marsico Clinical Research Center
  • Akron Children's Hospital
  • UC Health Holmes
  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
  • Nationwide Children's Hospital
  • Dayton Children's Hospital
  • ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
  • University of Oklahoma Health Sciences Center
  • Children's Hospital of Philadelphia
  • Medical University of South Carolina
  • Dell Children's Medical Center of Central Texas
  • The University of Texas Southwestern Medical Center
  • Vermont Lung Center
  • University of Virginia Primary Care Center
  • Children's Hospital of the King's Daughters
  • Children's Hospital of Richmond at VCU, Children's Pavilion
  • University of Washington Medical Center
  • West Virginia University
  • University of Wisconsin Hospitals and Clinics
  • CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital
  • Women & Children's Hospital
  • The Royal Children's Hospital
  • Mater Misericordiae Ltd
  • The Children's Hospital at Westmead
  • Westmead Hospital
  • University of Graz
  • Medizinische Universität Innsbruck
  • LKH - Universitätsklinikum der PMU Salzburg
  • Medizinische Universitat Wien
  • Cliniques Universitaires de Bruxelles Hopital Erasme
  • Universitair Ziekenhuis Brussel - Campus Jette
  • UZ Antwerpen
  • Universitair Ziekenhuis Gent
  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
  • University of Calgary Medical Clinic of the Foothills Medical Centre
  • McGill University Health Centre, Glen Site, Montreal Children's Hospital
  • Centre Hospitalier De L'Universite Laval
  • The Hospital for Sick Children
  • British Columbia's Children's Hospital
  • St. Paul's Hospital
  • Fakultni Nemocnice Brno
  • Fakultni nemocnice v Motole
  • Centre Hospitalier Lyon Sud
  • Groupe Hospitaler Pellegrin, CHU De Bordeaux
  • CHU Marseille - Hopital Nord
  • CHU de Nice - Hopital Pasteur
  • Hopital Cochin
  • CHU de Rouen - Hopital Charles Nicolle
  • Hopital Foch (Suresnes), Hopital Foch, Adultes
  • Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital
  • Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin
  • Hannover Medical School
  • Johannes Gutenberg-Universitaet
  • Dr. von Haunersches Kinderspital
  • Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin
  • University Hospital Wuerzburg
  • General Hospital of Attika "Sismanoglio"(Adult CF center, NHS)
  • Azienda Ospedaliero Universitaria Ospendali Riuniti
  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
  • IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico
  • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo
  • Azienda Ospedaliera di Verona-Ospedale Civile Maggiore
  • Academic Medical Center
  • HagaZiekenhuis van den Haag
  • University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis
  • UMC St. Radboud
  • Erasmus Medical Center
  • Karolinska Universitetssjukhuset, Huddinge
  • Belfast City Hospital
  • Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital
  • Western General Hospital
  • Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital
  • Leeds General Infirmary
  • King's College Hospital
  • Royal Manchester Children's Hospital
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label Triple Combination

Arm Description

Subjects will receive 200 mg VX-445/ 100 mg TEZ/ 150 mg IVA as FDC tablets in the morning and 150 mg IVA as mono tablet in the evening. Parent studies are Phase 3 Vertex studies investigating VX-445 in combination with TEZ and IVA. This includes Studies VX17-445-102 and VX17-445-103.

Outcomes

Primary Outcome Measures

Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1)
Absolute change in sweat chloride (SwCl)
Number of pulmonary exacerbations (PEx)
Time to first PEx
Absolute change in body mass index (BMI)
Absolute change in BMI z-score
Absolute change in body weight
Absolute change from baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score

Full Information

First Posted
May 2, 2018
Last Updated
February 7, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03525574
Brief Title
A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
Official 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 Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label Triple Combination
Arm Type
Experimental
Arm Description
Subjects will receive 200 mg VX-445/ 100 mg TEZ/ 150 mg IVA as FDC tablets in the morning and 150 mg IVA as mono tablet in the evening. Parent studies are Phase 3 Vertex studies investigating VX-445 in combination with TEZ and IVA. This includes Studies VX17-445-102 and VX17-445-103.
Intervention Type
Drug
Intervention Name(s)
VX-445
Intervention Description
Fixed-dose combination (FDC) tablets (VX-445/TEZ/IVA)
Intervention Type
Drug
Intervention Name(s)
TEZ
Other Intervention Name(s)
tezacaftor; VX-661
Intervention Description
FDC tablets (VX-445/TEZ/IVA)
Intervention Type
Drug
Intervention Name(s)
IVA
Other Intervention Name(s)
ivacaftor; VX-770
Intervention Description
FDC tablets (VX-445/TEZ/IVA)
Intervention Type
Drug
Intervention Name(s)
IVA
Other Intervention Name(s)
ivacaftor; VX-770
Intervention Description
IVA tablet
Primary Outcome Measure Information:
Title
Safety and tolerability as assessed by number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time Frame
from baseline through safety follow-up (up to 196 weeks)
Secondary Outcome Measure Information:
Title
Absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV1)
Time Frame
from baseline through last dose of study drug (up to 192 weeks)
Title
Absolute change in sweat chloride (SwCl)
Time Frame
from baseline through last dose of study drug (up to 192 weeks)
Title
Number of pulmonary exacerbations (PEx)
Time Frame
from baseline through last dose of study drug (up to 192 weeks)
Title
Time to first PEx
Time Frame
from baseline through last dose of study drug (up to 192 weeks)
Title
Absolute change in body mass index (BMI)
Time Frame
from baseline through last dose of study drug (up to 192 weeks)
Title
Absolute change in BMI z-score
Time Frame
from baseline through last dose of study drug (up to 192 weeks)
Title
Absolute change in body weight
Time Frame
from baseline through last dose of study drug (up to 192 weeks)
Title
Absolute change from baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) respiratory domain score
Time Frame
from baseline through last dose of study drug (up to 192 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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) Other protocol defined Inclusion/Exclusion criteria may apply.
Facility Information:
Facility Name
Banner University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Miller Children's Hospital / Long Beach Memorial
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
Kaiser Permanente
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSF Gateway Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Florida, Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Joe DiMaggio Cystic Fibrosis & Pulmonary Center
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nemours Children's Specialty Care
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Central Florida Pulmonary Group, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Tampa General Hospital Cardiac and Lung Transplant Clinic
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Children's Specialty Services at North Druid Hills
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30324
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Ann & Robert Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Cystic Fibrosis Center, Children's Hospital of Illinois at OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Maine Medical Partners
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Harper University Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Billings Clinic Hospital
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
UNM Clinical and Translational Science Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
The Cystic Fibrosis Center, Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
UNC Marsico Clinical Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
UC Health Holmes
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Vermont Lung Center
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
University of Virginia Primary Care Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Children's Hospital of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Children's Hospital of Richmond at VCU, Children's Pavilion
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
University of Wisconsin Hospitals and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
CTSI Adult Translational Research Unit/Medical College of Wisconsin/Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Women & Children's Hospital
City
North Adelaide
Country
Australia
Facility Name
The Royal Children's Hospital
City
Parkville
Country
Australia
Facility Name
Mater Misericordiae Ltd
City
South Brisbane
Country
Australia
Facility Name
The Children's Hospital at Westmead
City
Westmead
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Facility Name
University of Graz
City
Graz
Country
Austria
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
Country
Austria
Facility Name
LKH - Universitätsklinikum der PMU Salzburg
City
Salzburg
Country
Austria
Facility Name
Medizinische Universitat Wien
City
Vienna
Country
Austria
Facility Name
Cliniques Universitaires de Bruxelles Hopital Erasme
City
Brussels
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel - Campus Jette
City
Brussels
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Facility Name
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
University of Calgary Medical Clinic of the Foothills Medical Centre
City
Calgary
Country
Canada
Facility Name
McGill University Health Centre, Glen Site, Montreal Children's Hospital
City
Montreal
Country
Canada
Facility Name
Centre Hospitalier De L'Universite Laval
City
Quebec City
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
Country
Canada
Facility Name
British Columbia's Children's Hospital
City
Vancouver
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
Country
Canada
Facility Name
Fakultni Nemocnice Brno
City
Brno
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
Country
Czechia
Facility Name
Centre Hospitalier Lyon Sud
City
Benite Cedex
Country
France
Facility Name
Groupe Hospitaler Pellegrin, CHU De Bordeaux
City
Bordeaux cedex
Country
France
Facility Name
CHU Marseille - Hopital Nord
City
Marseille
Country
France
Facility Name
CHU de Nice - Hopital Pasteur
City
Nice
Country
France
Facility Name
Hopital Cochin
City
Paris
Country
France
Facility Name
CHU de Rouen - Hopital Charles Nicolle
City
Rouen
Country
France
Facility Name
Hopital Foch (Suresnes), Hopital Foch, Adultes
City
Suresnes
Country
France
Facility Name
Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital
City
Erlangen
Country
Germany
Facility Name
Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin
City
Giessen
Country
Germany
Facility Name
Hannover Medical School
City
Hannover
Country
Germany
Facility Name
Johannes Gutenberg-Universitaet
City
Mainz
Country
Germany
Facility Name
Dr. von Haunersches Kinderspital
City
München
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin
City
Tuebingen
Country
Germany
Facility Name
University Hospital Wuerzburg
City
Wurzburg
Country
Germany
Facility Name
General Hospital of Attika "Sismanoglio"(Adult CF center, NHS)
City
Maroussi
Country
Greece
Facility Name
Azienda Ospedaliero Universitaria Ospendali Riuniti
City
Ancona
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer
City
Firenze
Country
Italy
Facility Name
IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico
City
Genova
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Policlinico G. Martino
City
Messina
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo
City
Potenza
Country
Italy
Facility Name
Azienda Ospedaliera di Verona-Ospedale Civile Maggiore
City
Verona
Country
Italy
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
HagaZiekenhuis van den Haag
City
Den Haag
Country
Netherlands
Facility Name
University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis
City
Heidelberglaan
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
Karolinska Universitetssjukhuset, Huddinge
City
Stockholm
Country
Sweden
Facility Name
Belfast City Hospital
City
Belfast
Country
United Kingdom
Facility Name
Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital
City
Exeter
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33331662
Citation
Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.
Results Reference
derived

Learn more about this trial

A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

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