A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Participants With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation

PHASE3CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

August 16, 2017

Primary Completion Date

October 2, 2023

Study Completion Date

October 2, 2023

Conditions
Cystic Fibrosis
Interventions
DRUG

IVA

Granules for oral administration.

Trial Locations (29)

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Alfred I DuPont Hospital for Children, Wilmington

21287

John Hopkins Hospital, Baltimore

30329

Center for Advanced Pediatrics, Atlanta

32827

Nemours Children's Hospital, Orlando

35233

University of Alabama at Birmingham, Birmingham

43205

Nationwide Children's Hospital, Columbus

46202

Riley Hospital for Children at Indiana University Health, Indianapolis

53792

University of Wisconsin, Madison

55404

Childrens's Hospitals and Clinics of Minnnesota, Minneapolis

59101

Billings Clinic Hospital, Billings

60611

Northwestern University, Chicago

64108

Children's Mercy Hospital, Kansas City

77030

Texas Children's Hospital, Houston

94034

Stanford University, Palo Alto

98105

Seattle Children's Hospital, Seattle

02115

Boston Children's Hospital, Boston

Unknown

Queensland Children's Hospital, South Brisbane

The Hospital for Sick Children, Toronto

Universitaetsklinikum Heidelberg, Zenter fuer Kinder-und Jugendmedizin, Heidelberg

Children's Health Ireland at Crumlin, Dublin

Children's University Hospital Temple Street, Dublin

University Hospital Limerick, Limerick

Paediatric Clinical Research Facility, Edinburgh

Alder Hey Children's Alder Hey Children's NHS Foundation Trust, Liverpool

Great Ormond Street Hospital for Sick Children, London

Royal Brompton & Harefield NHS Founcation Trust, Royal BromptonHospital, London

Royal Manchester Children's Hospital, Manchester

Oxford University Hospitals NHS Trust, John Radcliffe Hospital, Oxford

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03277196 - A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Participants With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | Biotech Hunter | Biotech Hunter