A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

PHASE3CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

May 12, 2017

Primary Completion Date

July 17, 2019

Study Completion Date

July 17, 2019

Conditions
Cystic Fibrosis
Interventions
DRUG

LUM/IVA

Participants received LUM/IVA every q12h.

Trial Locations (20)

14222

The Lung & Cystic Fibrosis Center at Women's & Children's Hospital of Buffalo, Buffalo

19104

Children's Hospital of Philadelphia, Philadelphia

23507

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

27514

University of North Carolina Hospitals, Chapel Hill

29425

Medical University of South Carolina, Charleston

43205

Nationwide Children's Hospital, Columbus

44106

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

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children at Indiana University Health, Indianapolis

55404

Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minn, Minneapolis

60611

Ann & Robert Lurie Children's Hospital of Chicago, Chicago

64108

Children's Mercy Hospital, Kansas City

77030

Texas Children's Hospital, Houston

80045

Children's Hospital Colorado, Aurora

94305

Stanford University, Palo Alto

98105

Seattle Children's Hospital, Seattle

02115

Boston Children's Hospital, Boston

V6H 3N1

British Columbia's Children's Hospital, Vancouver

M5G 1X8

The Hospital for Sick Children, Toronto

H4A 3J1

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

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03125395 - A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Biotech Hunter | Biotech Hunter