A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation

PHASE3CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

April 25, 2018

Primary Completion Date

October 28, 2020

Study Completion Date

September 29, 2023

Conditions
Cystic Fibrosis
Interventions
DRUG

TEZ/IVA

Fixed-dose combination tablet for oral administration.

DRUG

IVA

Tablet for oral administration.

Trial Locations (55)

10032

Columbia University Medical Center, New York

13202

SUNY Upstate Medical University, Syracuse

14203

UBMD Pediatrics/ CF Center of Western New York, Buffalo

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19803

Nemours/ Alfred I. duPont Hospital for Children, Wilmington

23507

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

27157

Wake Forest Baptist Health, Winston-Salem

29425

Medical University of South Carolina (MUSC), Charleston

30329

Center for Advanced Pediatrics, Atlanta

33701

Johns Hopkins All Children's Hospital Outpatient Care Center, St. Petersburg

35233

University of Alabama at Birmingham, Birmingham

44106

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

46202

Riley Hospital for Children Indiana University Health, Indianapolis

53226

Children's Hospital of Wisconsin, Milwaukee

55404

Children's Hospital & Clinics of Minnesota, Minneapolis

57105

Sanford Children's Speciality Clinic, Sioux Falls

64108

The Children's Mercy Hospital, Kansas City

72202

Arkansas Children's Hospital, Little Rock

76104

Cook Children's Medical Center, Fort Worth

77030

Baylor College of Medicine, Houston

78723

Austin Children's Chest Associates, Austin

80045

Children's Hospital Colorado, Aurora

83702

St. Luke's CF Center of Idaho, Boise

90027

Children's Hospital Los Angeles, Los Angeles

98105

Seattle Children's Hospital, Seattle

99508

Providence Alaska Medical Center, Anchorage

02115

Boston Children's Hospital, Boston

03756

Dartmouth Hitchcock Medical Center, Manchester

Unknown

Perth Children's Hospital, Nedlands

John Hunter Hospital & Hunter Medical Research Institute and John Hunter Children's Hospital, New Lambton

Lady Cilento Children's Hospital, South Brisbane

The Children's Hospital at Westmead, Westmead

Universitair Ziekenhuis Brussel - Campus Jette, Brussels

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven

British Columbia's Children's Hospital, Vancouver

The Hospital for Sick Children, Toronto

McGill University Health Centre, Glen Site, Montreal Children's Hospital, Montreal

Juliane Marie Center, Rigshopitalet, Copenhagen

Groupe Hospitaler Pellegrin, CHU De Bordeaux, Bordeaux

Hopital Necker, Enfants Malades, Paris

Universitaetsklinkum Koeln, CF-Studienzentrum, Cologne

Universitätsklinikum Essen, Essen

Clinic of J.W. Goethe University, Frankfurt

Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin, Giessen

Medizinische Hochschule Hannover, Hanover

Universitaetsklinikum Jena, Mukoviszidose-Zentrum, Jena

Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin, Tübingen

Our Lady's Children's Hospital, Dublin

University Hospital Limerick, Limerick

Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY, Łomianki

Inselspital - Universitaetsspital Bern, Bern

Kinderspital Zuerich, Zurich

Leeds General Infirmary, Leeds

Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital, London

Southampton General Hospital, Southampton

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03537651 - A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation | Biotech Hunter | Biotech Hunter