Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

PHASE3CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

February 24, 2020

Primary Completion Date

August 22, 2023

Study Completion Date

August 22, 2023

Conditions
Cystic Fibrosis
Interventions
DRUG

LUM/IVA

LUM/IVA granules for oral administration

Trial Locations (23)

14642

University of Rochester Medical Center, Rochester

27157

Wake Forest University Baptist Medical Center, Winston-Salem

27599

NC TraCS Institute - CTRC University of North Carolina at Chapel Hill, Chapel Hill

30329

Children's Healthcare of Atlanta, Atlanta

35233

University of Alabama at Birmingham, Birmingham

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children at Indiana University Health, Indianapolis

53792

University of Wisconsin Hospital and Clinics, Madison

55404

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

60611

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

63104

Cardinal Glennon Children's Hospital - St. Louis University, St Louis

64108

The Children's Mercy Hospital, Kansas City

72202

Arkansas Children's Hospital, Little Rock

75235

Children's Medical Center of Dallas, Dallas

76104

Cook Children's Medical Center, Fort Worth

80045

Children's Hospital Colorado, Aurora

84132

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

98105

Seattle Children's Hospital, Seattle

06510

Yale New Haven Hospital, New Haven

02115

Boston Children's Hospital, Boston

Unknown

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

The Hospital for Sick Children, Toronto

British Columbia's Children's Hospital, Vancouver

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT04235140 - Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation | Biotech Hunter | Biotech Hunter