Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del

PHASE3CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

September 7, 2018

Primary Completion Date

October 29, 2021

Study Completion Date

October 29, 2021

Conditions
Cystic Fibrosis
Interventions
DRUG

LUM

Fixed Dose Combination (FDC) granules (LUM/IVA).

DRUG

IVA

FDC granules (LUM/IVA).

Trial Locations (27)

14642

University of Rochester Medical Center, Rochester

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Nemours / Alfred I. duPont Hospital for Children, Wilmington

21287

Johns Hopkins Hospital, Baltimore

27157

Wake Forest University School of Medicine - Brenner Children's Hospital, Winston-Salem

27514

University of North Carolina Hospitals, 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 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

94304

Stanford University, Palo Alto

98105

Seattle Children's Hospital, Seattle

06511

Yale New Haven Medical Center, 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

NCT03601637 - Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del | Biotech Hunter | Biotech Hunter