A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

PHASE3CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

August 3, 2018

Primary Completion Date

December 28, 2018

Study Completion Date

December 28, 2018

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-445/TEZ/IVA

Participants received VX-445/TEZ/IVA orally once daily in the morning.

DRUG

TEZ/IVA

Participants received TEZ/IVA orally once daily in the morning.

DRUG

IVA

Participants received IVA orally once daily in the evening.

DRUG

Placebo

Participants received placebo matched to VX-445/TEZ/IVA orally once daily in the morning.

DRUG

Placebo

Participants received placebo matched TEZ/IVA orally once daily in the morning.

Trial Locations (44)

10595

New York Medical College, Valhalla

19104

Children's Hospital of Philadelphia, Philadelphia

22908

University of Virginia Primary Care Center, Charlottesville

26506

West Virginia University, Morgantown

27517

UNC Marisco Clinical Research Center, Chapel Hill

29425

Medical University of South Carolina, Charleston

32803

Central Florida Pulmonary Group, PA, Orlando

32827

Nemours Children's Hospital, Orlando

33021

Joe DiMaggio Cystic Fibrosis & Pulmonary Center/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital, Hollywood

33606

Tampa General Hospital Cardiac and Lung Transplant Clinic, Tampa

43205

Nationwide Children's Hospital, Columbus

43606

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

44106

Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland

45404

Dayton Children's Hospital, Dayton

48201

Harper University Hospital, Detroit

60611

Northwestern Memorial Hospital, Chicago

61637

Saint Francis Medical Center/ Children's Hospital of Illinoise/OSF, Peoria

70112

Tulane Medical Center, New Orleans

72205

University of Arkansas for Medical Sciences, Little Rock

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75390

The University of Texas Southwestern Medical Center, Dallas

80206

National Jewish Health, Denver

85724

Banner University of Arizona Medical Center, Tucson

90027

Children's Hospital Los Angeles, Los Angeles

90806

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

93636

Valley Children's Hospital, Madera

02114

Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center, Boston

05446

Vermont Lung Center, Colchester

Unknown

Cliniques Universitaires de Bruxelles Hopital Erasme, Brussels

Universitair Ziekenhuis Brussel - Campus Jette, Brussels

UZ Antwerpen, Edegem

Universitair Ziekenhuis Gent, Ghent

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

Academic Medical Center, Amsterdam

University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis, Heidelberglaan

UMC St. Radboud, Nijmegen

Erasmus Medical Center, Rotterdam

HagaZiekenhuis van den Haag, The Hague

The Royal Belfast Hospital for Sick Children, Belfast

Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital, Birmingham

Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital, Exeter

Leeds General Infirmary, Leeds

King's College Hospital, London

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03525548 - A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F) | Biotech Hunter | Biotech Hunter