A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

PHASE2CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

April 17, 2019

Primary Completion Date

August 20, 2020

Study Completion Date

August 20, 2020

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-561

VX-561 tablets for oral administration.

DRUG

IVA

150-mg film-coated tablet for oral administration.

DRUG

Placebo

Placebo matched to IVA.

DRUG

Placebo

Placebos matched to VX-561.

Trial Locations (48)

10032

Columbia University Medical Center, New York

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

21287

Johns Hopkins Hospital, Baltimore

27514

University of North Carolina Hospitals, Chapel Hill

29425

Medical University of South Carolina, Charleston

32803

Central Florida Pulmonary Group, PA, Orlando

33136

University of Miami Miller School of Medicine, Miami

35233

University of Alabama at Birmingham, Birmingham

40536

University of Kentucky, Lexington

43606

ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center, Toledo

45220

UC Health Holmes, Cincinnati

46202

Indiana University, Indianapolis

53792

University of Wisconsin Hospital and Clinics, Madison

55455

University of Minnesota, Minneapolis

63104

Cardinal Glennon Children's Hospital, St Louis

63110

Washington University School of Medicine / St. Louis Children's Hospital, St Louis

66160

University of Kansas Medical Center, Kansas City

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

The University of Texas Southwestern Medical Center, Dallas

78723

Dell Children's Medical Group, Austin

80206

National Jewish Health, Denver

84132

University of Utah / Primary Children's Medical Center, Salt Lake City

85724

Banner University of Arizona Medical Center, Tucson

90806

Miller Children's Hospital / Long Beach Memorial, Long Beach

94143

UCSF Gateway Medical Center, San Francisco

02114

Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center, Boston

02115

Boston Children's Hospital, Boston

48109-5212

Michigan Medicine, Ann Arbor

03756

Dartmouth Hitchcock Medical Center, Lebanon

Unknown

The Prince Charles Hospital, Chermside

Alfred Hospital, Melbourne, VIC

Mater Adult Hospital, South Brisbane

Westmead Hospital, Westmead

Universitair Ziekenhuis Gent, Ghent

Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital, Erlangen

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Universitätsklinikum Halle (Saale) / Universitätsklinik und Poliklinik für Innere Medizin, Schwerpunkt Pneumologie, Halle

Pneumologisches Studienzentrum Muenchen-West, München

University Hospital Wuerzburg, Würzburg

Beaumont Hospital, Dublin

Cork University Hospital, Dublin

St. Vincent's University Hospital, Dublin

University Hospital Limerick (Adults), Limerick

UMC St. Radboud, Nijmegen

Clinical Research Facility, Queen Elizabeth University Hospital, Glasgow

St. James University Hospital, Leeds

Liverpool Heart and Chest Hospital, Liverpool

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03911713 - A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Biotech Hunter | Biotech Hunter