A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

PHASE3CompletedINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

May 1, 2018

Primary Completion Date

September 26, 2018

Study Completion Date

October 8, 2018

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-659/TEZ/IVA

Participants received VX-659/TEZ/IVA orally once daily in the morning.

DRUG

TEZ/IVA

Participants received TEZ/IVA orally once daily in the morning.

DRUG

IVA

Participants received IVA orally once daily in the evening.

DRUG

Placebo

Participants received placebo matched TEZ/IVA orally once daily in the morning.

DRUG

Placebo

Participants received placebo matched to VX-659/TEZ/IVA orally once daily in the morning.

Trial Locations (46)

10032

Columbia University Medical Center, New York

11040

Northwell Health, Long Island Jewish Medical Center, New Hyde Park

12208

Albany Medical College, Albany

13210

SUNY Upstate Medical University, Syracuse

15224

Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh

21287

The Johns Hopkins Hospital, Baltimore

33136

University of Miami/Miller School of Medicine, Miami

35233

University of Alabama at Birmingham, Birmingham

37232

Vanderbilt University Medical Center, Nashville

37920

University of Tennessee Medical Center-Adult Cystic Fibrosis Clinic, Knoxville

38103

Children's Foundation Research Center/ Le Bonheur Children's Hospital, Memphis

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Indiana Clinical Research Center, IU Health University Hospital, Indianapolis

49503

Helen DeVos Children's Hospital CF Center, Grand Rapids

52242

The University of Iowa Hospitals and Clinics, Iowa City

57105

Sanford Research/ USD, Sioux Falls

60714

Advocate Children's Hospital- Park Ridge/ North Suburban Pulmonary and Critical Care Consultants, Niles

63110

Washington University School of Medicine / St. Louis Children's Hospital, St Louis

64108

Children's Mercy Hospital, Kansas City

73211

Respiratory Diseases of Children and Adolescents, Oklahoma City

77030

Baylor College of Medicine, Houston

83712

St. Luke's CF Center of Idaho, Boise

84132

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

97239

Oregon Health & Science University, Portland

98105

Seattle Children's Hospital, Seattle

06511

Yale New Haven Medical Center, New Haven

02115

Boston Children's Hospital, Boston

08901

Rutgers-Robert Wood Johnson Medical School, New Brunswick

Unknown

The Alfred Hospital, Melbourne

Royal Adelaide Hospital, Adelaide

Prince Charles Hospital, Chermside

Institute for Respiratory Health Inc./ Sir Charles Gairdner Hospital, Nedlands

John Hunter Hospital & Hunter Medical Research Institute, New Lambton Heights

Charite Paediatric Pulmonology Department, Berlin

Pneumologische Praxis Pasing, München

Cork University Hospital, Dublin

Our Lady's Children's Hospital, Dublin

St. Vincent's University Hospital, Dublin

Hospital Universitari Vall d Hebron, Barcelona

Hospital Universitari Vall d'Hebron Servicio de Broncoscopia, Barcelona

Hospital Universitario Virgen del Rocio, Seville

Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge

Liverpool Heart and Chest Hospital, Liverpool

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

Wythenshawe Hospital, Manchester

University Hospital Llandough, Penarth

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03460990 - A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F) | Biotech Hunter | Biotech Hunter