A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
- Registration Number
- NCT04043806
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 458
- Currently participating in study VX17-659-105 (NCT03447262)
- History of drug intolerance in study VX17-659-105 that would pose an additional risk to the participant in the opinion of the investigator
- Current participation in an investigational drug trial (other than study VX17-659-105)
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ELX/TEZ/IVA IVA Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks. Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks. ELX/TEZ/IVA ELX/TEZ/IVA Part A: Participants received ELX 200 milligram (mg) once daily (qd),TEZ 100 mg qd, and IVA 150 mg every 12 hours (q12h) in the treatment period for 96 weeks. Part B: Participants from certain countries participated in Part B and continued to received ELX 200 mg qd /TEZ 100 mg qd/IVA 150 mg q12h in the treatment period for 48 weeks.
- Primary Outcome Measures
Name Time Method Part A: Safety and Tolerability as Assessed by Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) From Baseline through Week 100
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (97)
Cystic Fibrosis Institute
🇺🇸Glenview, Illinois, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Stanford University
🇺🇸Palo Alto, California, United States
Nicklaus Children's Hospital
🇺🇸Miami, Florida, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Johns Hopkins All Children's Hospital Outpatient Care Center
🇺🇸Saint Petersburg, Florida, United States
St. Luke's CF Center of Idaho
🇺🇸Boise, Idaho, United States
Arnold Palmer Hospital Pulmonary and Sleep Medicine
🇺🇸Orlando, Florida, United States
Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants
🇺🇸Niles, Illinois, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
The University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Kosair Charities Pediatric Clinical Research Unit
🇺🇸Louisville, Kentucky, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Michigan Medicine
🇺🇸Ann Arbor, Michigan, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Washington University School of Medicine / St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Albany Medical College, Pulmonary and Critical Care Medicine
🇺🇸Albany, New York, United States
Lung and Cystic Fibrosis Center at Women and Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Clinical Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
Northwell Health- Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Sanford Children's Speciality Clinic
🇺🇸Sioux Falls, South Dakota, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
Providence Pediatric Pulmonary & Cystic Fibrosis Clinic
🇺🇸Spokane, Washington, United States
The Prince Charles Hospital
🇦🇺Chermside, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Alfred Hospital
🇦🇺Melbourne, VIC, Australia
Institute for Respiratory Health
🇦🇺Nedlands, Australia
Perth Children's Hospital
🇦🇺Nedlands, Australia
Queensland Children's Hospital
🇦🇺South Brisbane, Australia
Queen Elizabeth II Health Sciences Center
🇨🇦Halifax, Canada
St. Michael's Hospital
🇨🇦Toronto, Canada
John Hunter Hospital & Hunter Medical Research Institute and John Hunter Children's Hospital
🇦🇺New Lambton, Australia
Stollery Children's Hospital
🇨🇦Edmonton, Canada
Charite Paediatric Pulmonology Department
🇩🇪Berlin, Germany
Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen
🇩🇪Essen, Germany
Johann Wolfgang Goethe University
🇩🇪Frankfurt, Germany
Universitaetsklinkum Koeln, CF-Studienzentrum
🇩🇪Koeln, Germany
Universitaetsklinikum Jena, Mukoviszidose-Zentrum
🇩🇪Jena, Germany
Hannover Medical School
🇩🇪Hannover, Germany
Universitatsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin
🇩🇪Lübeck, Germany
Pneumologisches Studienzentrum Muenchen-West
🇩🇪Muenchen, Germany
Klinikum Innenstadt, University of Munich
🇩🇪München, Germany
Beaumont Hospital
🇮🇪Dublin, Ireland
Cork University Hospital
🇮🇪Cork, Ireland
University Hospital Galway
🇮🇪Galway, Ireland
Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
University Hospital Limerick (Adults)
🇮🇪Limerick, Ireland
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Infantil La Paz
🇪🇸Madrid, Spain
Hospital Universitari Vall d´Hebron Servicio de Broncoscopia
🇪🇸Barcelona, Spain
Parc Tauli Sabadell Hospital Universitari
🇪🇸Sabadell, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario y Politecnico La Fe
🇪🇸Valencia, Spain
Lindenhofspital - Quartier Bleu
🇨🇭Bern, Switzerland
Kinderspital Zuerich
🇨🇭Zürich, Switzerland
NHS Greater Glasgow and Clyde, Gartnavel General Hospital
🇬🇧Glasgow, United Kingdom
Papworth Hospital NHS Foundation Trust, Papworth Everard
🇬🇧Cambridge, United Kingdom
St. James University Hospital
🇬🇧Leeds, United Kingdom
Liverpool Heart and Chest Hospital
🇬🇧Liverpool, United Kingdom
Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital
🇬🇧London, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, The Royal Victoria Infirmary
🇬🇧Newcastle Upon Tyne, United Kingdom
All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough
🇬🇧Penarth, United Kingdom
Nottingham University Hospitals NHS Trust, Queens Medical Center
🇬🇧Nottingham, United Kingdom
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah / Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
Pediatric Pulmonary Unit Rambam Medical Center
🇮🇱Haifa, Israel
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Children's Health Ireland at Crumlin
🇮🇪Dublin, Ireland
Children's Health Ireland at Temple Street
🇮🇪Dublin, Ireland
Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY
🇵🇱Łomianki, Poland
Children's Foundation Research Center / Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Schneider Children's Medical Center
🇮🇱Petah Tikva, Israel
Sheba Medical Center
🇮🇱Tel Hashomer, Israel
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hadassah Medical Organization
🇮🇱Jerusalem, Israel
Juliane Marie Center, Rigshospitalet
🇩🇰Copenhagen, Denmark
Santiago Reyes, M.D.
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
The Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain