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A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)

Primary Purpose

Cystic Fibrosis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
VX-121/TEZ/D-IVA
ELX/TEZ/IVA
IVA
Placebo (matched to VX-121/TEZ/D-IVA)
Placebo (matched to ELX/TEZ/IVA)
Placebo (matched to 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

Key Inclusion Criteria:

  • Heterozygous for F508del and a minimal function mutation (F/MF genotype)
  • Forced expiratory volume in 1 second (FEV1) value >=40% and <=90% of predicted mean for age, sex, and height for participants currently receiving ELX/TEZ/IVA therapy; FEV1 >=40% and <=80% for participants not currently receiving ELX/TEZ/IVA

Key Exclusion Criteria:

  • History of solid organ or hematological transplantation
  • Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
  • Lung infection with organisms associated with a more rapid decline in pulmonary status
  • Pregnant or breast-feeding females

Other protocol defined Inclusion/Exclusion criteria may apply

Sites / Locations

  • University of Alabama at Birmingham
  • Banner University of Arizona Medical Center
  • Arkansas Children's Hospital
  • Miller Children's Hospital / Long Beach Memorial
  • Children's Hospital Los Angeles
  • Kaiser Permanente
  • University of California Davis Medical Center
  • University of California San Francisco, Lung Transplant Program
  • Children's Hospital of Colorado
  • National Jewish Health
  • University of Florida, Shands Hospital
  • Joe DiMaggio Cystic Fibrosis & Pulmonary Center
  • Central Florida Pulmonary Group, PA
  • Nemours Children's Hospital
  • Johns Hopkins All Children's Hospital Outpatient Care Center
  • The Emory Clinic at Chantilly
  • Augusta University
  • St. Luke's Cystic Fibrosis Center of Idaho
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Northwestern Memorial Hospital
  • Indiana University
  • Riley Hospital for Children at Indiana University Health
  • University of Kansas Medical Center
  • University of Kentucky
  • Kosair Charities Pediatric Clinical Research Unit
  • Tulane Medical Center
  • Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
  • Boston Children's Hospital
  • UMass Memorial Medical Center
  • Michigan Medicine
  • Helen DeVos Children's Hospital CF Center
  • University of Minnesota
  • University of Mississippi Medical Center
  • Childrens Hospital University of Missouri Health Sciences Center
  • The Children's Mercy Hospital
  • Cardinal Glennon Children's Hospital - St. Louis University
  • Washington University School of Medicine / St. Louis Children's Hospital
  • Billings Clinic
  • Nebraska Medical Center
  • Dartmouth Hitchcock, Manchester
  • Morristown Medical Center
  • Albany Medical College
  • CF Therapeutics Development Center of Western New York
  • Northwell Health- Long Island Jewish Medical Center
  • Columbia University Medical Center
  • New York Medical College
  • Atrium Health Levine Children's Hospital
  • Wake Forest Baptist Health
  • Cleveland Clinic CF
  • Nationwide Children's Hospital
  • Dayton Children's Hospital
  • ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center
  • Oregon Health & Science University
  • Children's Hospital of Philadelphia
  • UPMC Children's Hospital of Pittsburgh
  • Sanford Children's Speciality Clinic
  • University of Tennessee Medical Center
  • Children's Foundation Research Center / Le Bonheur Children's Hospital
  • Vanderbilt University Medical Center
  • Driscoll Children's Hospital
  • The University of Texas Southwestern Medical Center
  • Cook Children's Health Care System
  • Texas Children's Hospital - Baylor College of Medicine
  • University of Utah - Primary Children's Medical Center
  • Vermont Lung Center
  • University of Virginia Health System
  • Inova Fairfax
  • University of Washington Medical Center
  • University of Wisconsin Hospital and Clinics
  • Royal Prince Alfred Hospital
  • The Prince Charles Hospital
  • Alfred Hospital
  • Mater Adult Hospital
  • Queensland Children's Hospital
  • Westmead Hospital
  • Klinika Detskych Infekcnich Nemoci
  • Fakultni nemocnice v Motole
  • Charite Paediatric Pulmonology Department
  • St. Josef-Hospital
  • Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital
  • Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
  • Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie
  • Johann Wolfgang Goethe University
  • Hannover Medical School
  • Medizinische Hochschule Hannover
  • Mukoviszidose-Zentrum am Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
  • Johannes Gutenberg-Universitaet
  • Pneumologisches Studienzentrum Muenchen-West
  • Klinikum Innenstadt, University of Munich
  • Klinikum Westbrandenburg (CF)
  • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF)
  • Universitätsklinikum Würzburg
  • National Koranyi Institute for TBC and Pulmonology
  • Pulmonology Institute Torokbalint
  • Cork University Hospital
  • Children's Health Ireland at Crumlin
  • Children's Health Ireland at Tallaght
  • Children's Health Ireland at Temple Street
  • St. Vincent's University Hospital
  • University Hospital Limerick (Adults)
  • University Hospital Limerick (Pediatrics)
  • Hadassah University Hospital Mount Scopus
  • Schneider Children's Medical Center of Israel
  • Sheba Medical Center - The Edmond and Lili Safra Children's Hospital
  • Greenlane Clinical Centre
  • Starship Children's Hospital
  • Canterbury Respiratory Research Group
  • Waikato Hospital
  • Hospital de Santa Maria
  • CHP - Hospital de Santo Antonio
  • Hospital Sao Joao
  • Hospital Saint Joan de Deu
  • Hospital Universitari Vall d Hebron
  • Hospital Infantil Universitario Nino Jesus
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Ramon y Cajal
  • Hospital Virgen de la Arrixaca
  • Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari
  • Hospital Universitario Virgen del Rocio
  • Hospital Universitario y Politecnico La Fe
  • Sahlgrenska Universitetssjukhuset
  • Lund University Skanes Universitetssjukhus
  • Karolinska Universitetssjukhuset, Huddinge
  • Birmingham Heartlands Hospital
  • University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital
  • Royal Papworth Hospital NHS Foundation Trust
  • Royal Hospital for Sick Children
  • Western General Hospital
  • Royal Devon and Exeter Hospital
  • Clinical Research Facility, Queen Elizabeth University Hospital
  • St. James University Hospital
  • Liverpool Heart and Chest Hospital
  • King's College Hospital
  • Royal Brompton Hospital
  • St. Bartholomew's Hospital
  • Wythenshawe Hospital
  • Clinical Research Facility
  • All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough
  • Southampton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VX-121/TEZ/D-IVA

ELX/TEZ/IVA

Arm Description

Participants will receive VX-121/TEZ/D-IVA in the morning.

Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.

Outcomes

Primary Outcome Measures

Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24

Secondary Outcome Measures

Absolute Change From Baseline in Sweat Chloride (SwCl) Through Week 24
Proportion of Participants With SwCl <60 Millimole per Liter (mmol/L) Through Week 24 (Pooled With Data From Study VX20-121-103)
Proportion of Participants With SwCl <30 mmol/L Through Week 24 (Pooled With Data From Study VX20-121-103)

Full Information

First Posted
August 26, 2021
Last Updated
June 9, 2023
Sponsor
Vertex Pharmaceuticals Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT05033080
Brief Title
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
Official Title
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
May 12, 2023 (Actual)
Study Completion Date
January 2024 (Anticipated)

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

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who are heterozygous for F508del and a minimal function mutation (F/MF participants).

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 ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VX-121/TEZ/D-IVA
Arm Type
Experimental
Arm Description
Participants will receive VX-121/TEZ/D-IVA in the morning.
Arm Title
ELX/TEZ/IVA
Arm Type
Active Comparator
Arm Description
Participants will receive ELX/TEZ/IVA in the morning and IVA in the evening.
Intervention Type
Drug
Intervention Name(s)
VX-121/TEZ/D-IVA
Other Intervention Name(s)
VX-121/VX-661/CTP-656, VX-121/VX-661/VX-561, VX-121/tezacaftor/deutivacaftor
Intervention Description
Fixed-dose combination tablets for oral administration.
Intervention Type
Drug
Intervention Name(s)
ELX/TEZ/IVA
Other Intervention Name(s)
VX-445/VX-661/VX-770, elexacaftor/tezacaftor/ivacaftor
Intervention Description
Fixed-dose combination tablets for oral administration.
Intervention Type
Drug
Intervention Name(s)
IVA
Other Intervention Name(s)
VX-770, ivacaftor
Intervention Description
Tablet for oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo (matched to VX-121/TEZ/D-IVA)
Intervention Description
Placebo matched to VX-121/TEZ/D-IVA for oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo (matched to ELX/TEZ/IVA)
Intervention Description
Placebo matched to ELX/TEZ/IVA for oral administration.
Intervention Type
Drug
Intervention Name(s)
Placebo (matched to IVA)
Intervention Description
Placebo matched to IVA for oral administration.
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 24
Time Frame
From Baseline Through Week 24
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline in Sweat Chloride (SwCl) Through Week 24
Time Frame
From Baseline Through Week 24
Title
Proportion of Participants With SwCl <60 Millimole per Liter (mmol/L) Through Week 24 (Pooled With Data From Study VX20-121-103)
Time Frame
From Baseline Through Week 24
Title
Proportion of Participants With SwCl <30 mmol/L Through Week 24 (Pooled With Data From Study VX20-121-103)
Time Frame
From Baseline Through Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Heterozygous for F508del and a minimal function mutation (F/MF genotype) Forced expiratory volume in 1 second (FEV1) value >=40% and <=90% of predicted mean for age, sex, and height for participants currently receiving ELX/TEZ/IVA therapy; FEV1 >=40% and <=80% for participants not currently receiving ELX/TEZ/IVA Key Exclusion Criteria: History of solid organ or hematological transplantation Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15) Lung infection with organisms associated with a more rapid decline in pulmonary status Pregnant or breast-feeding females 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
Banner University of Arizona Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
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
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
University of California San Francisco, Lung Transplant Program
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Children's Hospital of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
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
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
Johns Hopkins All Children's Hospital Outpatient Care Center
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
The Emory Clinic at Chantilly
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
St. Luke's Cystic Fibrosis Center of Idaho
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Ann & Robert H. 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
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Riley Hospital for Children at Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky
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
Tulane Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5212
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
Childrens Hospital University of Missouri Health Sciences Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Cardinal Glennon Children's Hospital - St. Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
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
Billings Clinic
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
Dartmouth Hitchcock, Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03104
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
CF Therapeutics Development Center of Western New York
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
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
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Atrium Health Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Cleveland Clinic CF
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Sanford Children's Speciality Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
University of Tennessee Medical Center
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
38105
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8558
Country
United States
Facility Name
Cook Children's Health Care System
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Children's Hospital - 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
Vermont Lung Center
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne, VIC
Country
Australia
Facility Name
Mater Adult Hospital
City
South Brisbane
Country
Australia
Facility Name
Queensland Children's Hospital
City
South Brisbane
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Facility Name
Klinika Detskych Infekcnich Nemoci
City
Brno
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
Country
Czechia
Facility Name
Charite Paediatric Pulmonology Department
City
Berlin
Country
Germany
Facility Name
St. Josef-Hospital
City
Bochum
Country
Germany
Facility Name
Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital
City
Erlangen
Country
Germany
Facility Name
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
City
Essen
Country
Germany
Facility Name
Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie
City
Essen
Country
Germany
Facility Name
Johann Wolfgang Goethe University
City
Frankfurt
Country
Germany
Facility Name
Hannover Medical School
City
Hannover
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
Country
Germany
Facility Name
Mukoviszidose-Zentrum am Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin
City
Jena
Country
Germany
Facility Name
Johannes Gutenberg-Universitaet
City
Mainz
Country
Germany
Facility Name
Pneumologisches Studienzentrum Muenchen-West
City
Muenchen
Country
Germany
Facility Name
Klinikum Innenstadt, University of Munich
City
München
Country
Germany
Facility Name
Klinikum Westbrandenburg (CF)
City
Potsdam
Country
Germany
Facility Name
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF)
City
Ulm
Country
Germany
Facility Name
Universitätsklinikum Würzburg
City
Würzburg
Country
Germany
Facility Name
National Koranyi Institute for TBC and Pulmonology
City
Budapest
Country
Hungary
Facility Name
Pulmonology Institute Torokbalint
City
Torokbalint
Country
Hungary
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Children's Health Ireland at Crumlin
City
Dublin
Country
Ireland
Facility Name
Children's Health Ireland at Tallaght
City
Dublin
Country
Ireland
Facility Name
Children's Health Ireland at Temple Street
City
Dublin
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
University Hospital Limerick (Adults)
City
Limerick
Country
Ireland
Facility Name
University Hospital Limerick (Pediatrics)
City
Limerick
Country
Ireland
Facility Name
Hadassah University Hospital Mount Scopus
City
Jerusalem
Country
Israel
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tikvah
Country
Israel
Facility Name
Sheba Medical Center - The Edmond and Lili Safra Children's Hospital
City
Tel HaShomer
Country
Israel
Facility Name
Greenlane Clinical Centre
City
Auckland
Country
New Zealand
Facility Name
Starship Children's Hospital
City
Auckland
Country
New Zealand
Facility Name
Canterbury Respiratory Research Group
City
Christchurch Hospital
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
Hospital de Santa Maria
City
Lisbon
Country
Portugal
Facility Name
CHP - Hospital de Santo Antonio
City
Porto
Country
Portugal
Facility Name
Hospital Sao Joao
City
Porto
Country
Portugal
Facility Name
Hospital Saint Joan de Deu
City
Barcelona
Country
Spain
Facility Name
Hospital Universitari Vall d Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Infantil Universitario Nino Jesus
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari
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
Sahlgrenska Universitetssjukhuset
City
Göteborg
Country
Sweden
Facility Name
Lund University Skanes Universitetssjukhus
City
Malmoe
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset, Huddinge
City
Stockholm
Country
Sweden
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
Country
United Kingdom
Facility Name
University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital
City
Bristol
Country
United Kingdom
Facility Name
Royal Papworth Hospital NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
Country
United Kingdom
Facility Name
Clinical Research Facility, Queen Elizabeth University Hospital
City
Glasgow
Country
United Kingdom
Facility Name
St. James University Hospital
City
Leeds
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
Country
United Kingdom
Facility Name
King's College Hospital
City
London
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Facility Name
St. Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
Country
United Kingdom
Facility Name
Clinical Research Facility
City
Newcastle Upon Tyne
Country
United Kingdom
Facility Name
All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough
City
Penarth
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Learn more about this trial

A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)

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