A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)

PHASE3CompletedINTERVENTIONAL
Enrollment

98

Participants

Timeline

Start Date

May 24, 2017

Primary Completion Date

August 9, 2018

Study Completion Date

August 9, 2018

Conditions
Cystic Fibrosis
Interventions
DRUG

Tezacaftor/Ivacaftor

TEZ 100 mg/IVA 150 mg fixed-dose combination tablet.

DRUG

Ivacaftor

IVA 150 mg tablet.

DRUG

Placebo

Placebo matched to TEZ/IVA fixed-dose combination tablet.

DRUG

Placebo

Placebo matched to IVA tablet.

Trial Locations (53)

10003

Mount Sinai Beth Israel, New York

10595

New York Medical College, Valhalla

19107

Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center, Philadelphia

23298

Children's Hospital of Richmond at VCU, Children's Pavilion, Richmond

23507

Children's Hospital of the King's Daughters, Norfolk

27157

Wake Forest University Baptist Medical Center, Winston-Salem

27710

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

30324

Children's Speciality Services at North Druid Hills, Atlanta

32803

Central Florida Pulmonary Group, Orlando

32806

Arnold Palmer Hospital, Orlando

33606

Tampa General Hospital Cardiac and Lung Transplant Clinic, Tampa

35233

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

37920

The University of Tennessee Medical Center, Nashville

39216

University of Mississippi Medical Center, Jackson

40536

Kentucky Clinic, Lexington

44195

Cleveland Clinic Foundation, Cleveland

46202

Riley Hospital for Children at Indiana University Health, Indianapolis

52242

The University of Iowa Hospitals and Clinics, Iowa City

59101

Billings Clinic, Billings

60714

Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants, Niles

62702

Southern Illinois University, Springfield

64108

Children's Mercy Hospital, Kansas City

66160

University of Kansas Medical Center, Kansas City

70112

Tulane Medical Center, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

73112

Santiago Reyes, M.D., Oklahoma City

78207

The University of Texas Health Science Center at San Antonio, San Antonio

78723

Dell Children's Medical Center of Central Texas, Austin

80206

National Jewish Health, Denver

83702

St. Luke's CF Center of Idaho, Boise

84132

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

85016

Phoenix Children's Hospital, Phoenix

90027

Children's Hospital Los Angeles, Los Angeles

90806

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

92123

Rady Children's Hospital, San Diego

93701

UCSF - Fresno, Community Regional Medical Center, Fresno

06510

Yale New Haven Hospital, New Haven

02114

Massachusetts General Hospital Cystic Fibrosis Center, Boston

02115

Boston Children's Hospital, Boston

Unknown

Centre Hospitalier Intercommunal de Créteil, Créteil

Centre Hospitalier Universitaire De Grenoble - Hopital Michallon, Grenoble

CHU de Montpellier - Hopital Arnaud de Villeneuve, Montpellier

Centre Hospitalier Universitaire De Nantes, Nantes

Centre hospitalier universitaire de Nice, Pulmonology, Nice

Hopital Cochin, Paris

Centre Hospitalier Universitaire - Hopitaux de Rouen, Rouen

Charite Paediatric Pulmonology Department, Berlin

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Klinikum Innenstadt, University of Munich, München

Pneumologische Praxis Pasing, München

Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin, Tübingen

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03150719 - A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF) | Biotech Hunter | Biotech Hunter