Back to resultsA Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VX-659/TEZ/IVA
IVA
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Key Inclusion Criteria:
- Heterozygous for F508del and an MF mutation (as defined in the protocol)
- Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height
Key Exclusion Criteria:
- Clinically significant cirrhosis with or without portal hypertension
- Lung infection with organisms associated with a more rapid decline in pulmonary status
- Solid organ or hematological transplantation
Other protocol defined Inclusion/Exclusion criteria may apply
Sites / Locations
- University of Alabama at Birmingham
- Stanford University
- Children's Hospital Colorado
- Hartford Health
- Yale New Haven Medical Center
- University of Miami/ Miller School of Medicine
- Nicklaus Children's Hospital
- Arnold Palmer Hospital
- Johns Hopkins All Children's Hospital Outpatient Care Center
- St. Luke's CF Center of Idaho
- Cystic Fibrosis Center of Chicago
- Advocate Children's Hospital - Park Ridge/ North Suburban Pulmonary and Critical Care Consultants
- Indiana Clinical Research Center, IU Health University Hospital
- The University of Iowa Hospitals and Clinics
- Kentucky Clinic
- Kosair Charities Pediatric Clinical Research Unit
- The Johns Hopkins Hospital
- Boston Children's Hospital
- University of Massachusetts Memorial Medical Center
- University of Michigan Health System
- Helen DeVos Children's Hospital CF Center
- University of Minnesota
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Washington University School of Medicine/ St. Louis Children's Hospital
- Dartmouth Hitchcock Medical Center, Lebanon
- Rutgers-Robert Wood Johnson Medical School
- Albany Medical College
- Lung and Cystic Fibrosis Center at Women and Children's Hospital of Buffalo
- Northwell Health, Long Island Jewish Medical Center
- Columbia University Medical Center
- SUNY Upstate Medical University
- Clinical Research of Charlotte
- Duke University Medical Center
- Cincinnati Children's Hospital Medical Center
- Respiratory Diseases of Children and Adolescents
- Oregon Health & Science University
- Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center
- Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
- Sanford Research/ USD
- University of Tennessee Medical Center - Adult Cystic Fibrosis Clinic
- Children's Foundation Research Center/ Le Bonheur Children's Hospital
- Vanderbilt University Medical Center
- Cook Children's Medical Center
- Baylor College of Medicine
- University of Utah / Primary Children's Medical Center
- Seattle Children's Hospital
- Providence Pediatric Pulmonary & Allergy/Immunology Clinic
- The Alfred Hospital
- Royal Adelaide Hospital
- Prince Charles Hospital
- Royal Brisbane & Women's Hospital
- Institute for Respiratory Health Inc./ Sir Charles Gairdner Hospital
- John Hunter Hospital & Hunter Medical Research Institute
- Sydney Children's Hospital, Randwick
- Princess Margaret Hospital for Children
- Stollery Children's Hospital
- Queen Elizabeth II Health Sciences Center
- St. Michael's Hospital
- Juliane Marie Center, Rigshospitalet
- Charite Paediatric Pulmonology Department
- Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
- Clinic of J.W Goethe University
- Medizinische Hochschule Hannover
- Mukeviszidose-Zentrum am Universitatsklinikum Jena, Klinik fuer Kinder - und Jugendmedizin
- University Hospital Cologne
- Universitatsklinikum Schleswig-Holstein, Klinik fur Kinder- und Jugendmedizin
- Pneumologische Praxis Pasing
- Klinikum Innenstadt, University of Munich
- Beaumont Hospital
- Children's University Hospital Temple Street
- Cork University Hospital
- Our Lady's Children's Hospital
- St. Vincent's University Hospital
- National University of Ireland
- University Hospital Limerick
- Lady Davis Carmel Medical Center
- Pediatric Pulmonary Unit Rambam Medical Center
- Hadassah Medical Organization
- Schneider Children's Medical Center
- Sheba Medical Center
- Instytut Matki i Dziecka
- Hospital Universitari Vall d Hebron
- Hospital Universitari Vall d'Hebron Servicio de Broncoscopia
- Hospital Universitario 12 de Octubre
- Hospital Universitario Infantil La Paz
- Coporacio Sanitaria Parc Tauli
- Hospital Universitario Virgen del Rocio
- Hospital Universitario y Politecnico La Fe
- Lindenhofspital - Quartier Bleu
- Kinderspital Zuerich
- Universitaetsspital Zuerich
- Papworth Hospital NHS Foundation Trust, Papworth Everard
- Queen Elizabeth University Hospital
- The Leeds Teaching Hospitals NHS Trust, St. James University Hospital
- Liverpool Heart and Chest Hospital
- Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital
- Wythenshawe Hospital
- The Newcastle Upon Tyne Hospitals NHS Foundation Trust, The Royal Victoria Infirmary
- Nottingham University Hospitals NHS Trust, Queens Medical Center
- University Hospital Llandough
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
VX-659/TEZ/IVA TC
Arm Description
Participants who received placebo matched to VX-659/TEZ/IVA for 24 weeks in the TC treatment period.
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as fixed-dose combination (FDC) tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
Outcomes
Primary Outcome Measures
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Secondary Outcome Measures
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Number of Pulmonary Exacerbations (PEx)
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Absolute Change in Sweat Chloride (SwCl)
Sweat samples were collected using an approved collection device.
Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Absolute Change in Body Mass Index (BMI)
BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).
Absolute Change in Sweat Chloride
Sweat samples were collected using an approved collection device.
Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Time-to-first Pulmonary Exacerbation (PEx)
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Absolute Change in BMI Z-score for Participants <=20 Years of Age at Baseline
BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to describe whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI.
Absolute Change in Body Weight
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
Full Information
NCT ID
NCT03447249
First Posted
February 21, 2018
Last Updated
March 12, 2020
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT03447249
Brief Title
A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
Official Title
A Phase 3, Randomized, 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 Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
February 5, 2019 (Actual)
Study Completion Date
February 5, 2019 (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 efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
385 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants who received placebo matched to VX-659/TEZ/IVA for 24 weeks in the TC treatment period.
Arm Title
VX-659/TEZ/IVA TC
Arm Type
Experimental
Arm Description
Participants who received VX-659 240 mg/TEZ 100 mg/IVA 150 mg as fixed-dose combination (FDC) tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
Intervention Type
Drug
Intervention Name(s)
VX-659/TEZ/IVA
Other Intervention Name(s)
VX-659/VX-661/VX-770, VX-659/tezacaftor/ivacaftor
Intervention Description
Participants received VX-659/TEZ/IVA orally once daily in the morning.
Intervention Type
Drug
Intervention Name(s)
IVA
Other Intervention Name(s)
VX-770, ivacaftor
Intervention Description
Participants received IVA orally once daily in the evening.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants received placebo matched VX-659/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.
Primary Outcome Measure Information:
Title
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Description
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Time Frame
From Baseline at Week 4
Secondary Outcome Measure Information:
Title
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
Description
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Time Frame
From Baseline through Week 24
Title
Number of Pulmonary Exacerbations (PEx)
Description
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Time Frame
From Baseline through Week 24
Title
Absolute Change in Sweat Chloride (SwCl)
Description
Sweat samples were collected using an approved collection device.
Time Frame
From Baseline through Week 24
Title
Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score
Description
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Time Frame
From Baseline through Week 24
Title
Absolute Change in Body Mass Index (BMI)
Description
BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2).
Time Frame
From Baseline at Week 24
Title
Absolute Change in Sweat Chloride
Description
Sweat samples were collected using an approved collection device.
Time Frame
From Baseline at Week 4
Title
Absolute Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) Respiratory Domain Score
Description
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Time Frame
From Baseline at Week 4
Title
Time-to-first Pulmonary Exacerbation (PEx)
Description
Pulmonary exacerbation was defined as the treatment with new or changed antibiotic therapy (intravenous, inhaled, or oral) for greater than or equal to 4 sinopulmonary signs/symptoms.
Time Frame
From Baseline through Week 24
Title
Absolute Change in BMI Z-score for Participants <=20 Years of Age at Baseline
Description
BMI was defined as weight in kg divided by height in m^2. z-score is a statistical measure to describe whether a mean was above or below the standard. BMI, adjusted for age and sex, was analyzed as BMI-for-age z-score. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of higher BMI.
Time Frame
From Baseline at Week 24
Title
Absolute Change in Body Weight
Time Frame
From Baseline at Week 24
Title
Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
From first dose of study drug in TC treatment period up to 28 days after last dose of study drug or to the completion of study participation date, whichever occurs first (up to 28 weeks)
Title
Observed Pre-dose Concentration (Ctrough) of VX-659, TEZ, M1-TEZ, and IVA
Time Frame
Pre-dose on Week 4, 8, 12, and 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Heterozygous for F508del and an MF mutation (as defined in the protocol)
Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height
Key Exclusion Criteria:
Clinically significant cirrhosis with or without portal hypertension
Lung infection with organisms associated with a more rapid decline in pulmonary status
Solid organ or hematological transplantation
Other protocol defined Inclusion/Exclusion criteria may apply
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hartford Health
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale New Haven Medical Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
University of Miami/ Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Arnold Palmer Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Johns Hopkins All Children's Hospital Outpatient Care Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
St. Luke's CF Center of Idaho
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Cystic Fibrosis Center of Chicago
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60025
Country
United States
Facility Name
Advocate Children's Hospital - Park Ridge/ North Suburban Pulmonary and Critical Care Consultants
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Indiana Clinical Research Center, IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
The University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kentucky Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Kosair Charities Pediatric Clinical Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Helen DeVos Children's Hospital CF Center
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School of Medicine/ St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center, Lebanon
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Rutgers-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
80901
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Lung and Cystic Fibrosis Center at Women and Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14222
Country
United States
Facility Name
Northwell Health, Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Clinical Research of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Respiratory Diseases of Children and Adolescents
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19017
Country
United States
Facility Name
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Sanford Research/ USD
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
University of Tennessee Medical Center - Adult Cystic Fibrosis Clinic
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Children's Foundation Research Center/ Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah / Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Providence Pediatric Pulmonary & Allergy/Immunology Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
Prince Charles Hospital
City
Chermside
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
Country
Australia
Facility Name
Institute for Respiratory Health Inc./ Sir Charles Gairdner Hospital
City
Nedlands
Country
Australia
Facility Name
John Hunter Hospital & Hunter Medical Research Institute
City
New Lambton Heights
Country
Australia
Facility Name
Sydney Children's Hospital, Randwick
City
Randwick
Country
Australia
Facility Name
Princess Margaret Hospital for Children
City
Subiaco
Country
Australia
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
Country
Canada
Facility Name
Juliane Marie Center, Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Charite Paediatric Pulmonology Department
City
Berlin
Country
Germany
Facility Name
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
City
Essen
Country
Germany
Facility Name
Clinic of J.W Goethe University
City
Frankfurt
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Mukeviszidose-Zentrum am Universitatsklinikum Jena, Klinik fuer Kinder - und Jugendmedizin
City
Jena
Country
Germany
Facility Name
University Hospital Cologne
City
Koeln
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein, Klinik fur Kinder- und Jugendmedizin
City
Lubeck
Country
Germany
Facility Name
Pneumologische Praxis Pasing
City
Muenchen
Country
Germany
Facility Name
Klinikum Innenstadt, University of Munich
City
München
Country
Germany
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Facility Name
Children's University Hospital Temple Street
City
Dublin
Country
Ireland
Facility Name
Cork University Hospital
City
Dublin
Country
Ireland
Facility Name
Our Lady's Children's Hospital
City
Dublin
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
National University of Ireland
City
Galway
Country
Ireland
Facility Name
University Hospital Limerick
City
Limerick
Country
Ireland
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Pediatric Pulmonary Unit Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petah tikva
Country
Israel
Facility Name
Sheba Medical Center
City
Tel HaShomer
Country
Israel
Facility Name
Instytut Matki i Dziecka
City
Warsaw
Country
Poland
Facility Name
Hospital Universitari Vall d Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron Servicio de Broncoscopia
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Infantil La Paz
City
Madrid
Country
Spain
Facility Name
Coporacio Sanitaria Parc Tauli
City
Sabadell
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
Country
Spain
Facility Name
Lindenhofspital - Quartier Bleu
City
Bern
Country
Switzerland
Facility Name
Kinderspital Zuerich
City
Zürich
Country
Switzerland
Facility Name
Universitaetsspital Zuerich
City
Zürich
Country
Switzerland
Facility Name
Papworth Hospital NHS Foundation Trust, Papworth Everard
City
Cambridge
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
Country
United Kingdom
Facility Name
The Leeds Teaching Hospitals NHS Trust, St. James University Hospital
City
Leeds
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
Country
United Kingdom
Facility Name
Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital
City
London
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
Country
United Kingdom
Facility Name
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, The Royal Victoria Infirmary
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust, Queens Medical Center
City
Nottingham
Country
United Kingdom
Facility Name
University Hospital Llandough
City
Penarth
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
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