A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis

PHASE2CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

August 8, 2017

Primary Completion Date

February 28, 2018

Study Completion Date

February 28, 2018

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-659

Tablet for oral administration.

DRUG

TEZ/IVA

TEZ/IVA fixed-dose combination tablet for oral administration.

DRUG

IVA

Tablet for oral administration.

DRUG

Placebo (matched to VX-659/TEZ/IVA)

Placebo matched to VX-659 and TEZ/IVA.

DRUG

TEZ

Tablet for oral administration.

DRUG

VX-561

Tablet for oral administration.

DRUG

Placebo (matched to VX-659/TEZ/VX-561)

Placebo matched to VX-659, TEZ and VX-561.

Trial Locations (47)

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/ Johns Hopkins Hospital, David Rubenstein Child Health Building, Baltimore

33136

University of Miami/Miller School of Medicine, Miami

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

46202

Indiana University Health, Indianapolis

48109

University of Michigan Health System, Ann Arbor

49503

Helen DeVos Children's Hospital CF Center, Grand Rapids

52242

The University of Iowa Hospitals and Clinics, Iowa City

57104

Sanford Research / USD, Sioux Falls

60053

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

64108

Children's Mercy Hospital, Kansas City

73112

Respiratory Diseases of Children & Adolescents, Oklahoma City

84014

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

98105

Seattle Children's Hospital, Seattle

99204

Providence Pediatric Pulmonary & Allergy/Immunology Clinic, Spokane

06520

Yale New Haven Hospital, New Haven

02155

Boston Children's Hospital, Boston

01655

University of Massachusetts Memorial Medical Center, Worcester

08902

Rutgers-Robert Wood Johnson Medical School/ Rutgers-Robert Wood Johnson Medical School, Clinical Research Center, New Brunswick

Unknown

Cork University Hospital, Cork

St. Vincent's University Hosptial, Dublin

Galway University Hospitals, Galway

University Hospital Limerick, Limerick

Carmel Medical Center, Haifa

Ruth Children's Hospital Rambam Health Care Campus, Haifa

Hadassah Medical Organization, Jerusalem

The Chaim Sheba medical center, Ramat Gan

Schneider Children's Medical Center, Tikvah

Papworth Hospital NHS Foundation Trust, Papworth Everard, Cambridge

University Hospital Llandough in Cardiff, Cardiff

Royal Devon and Exeter NHS Foundation Trust, Royal Devon and Exeter Hospital, Devon

The Newcastle upon Tyne Hospitals NHS Foundation Trust, The Royal Victoria Infirmary, Fulham

Greater Glasgow and Clyde NHS Board, Glasgow Clinical Research Facility, Glasgow

Southampton University Hospitals NHS Foundation Trust, Hampshire

Regional Respiratory Centre Belfast City Hospital, London

Royal Brompton & Harefied NHS Foundation Trust, London

University Hospital of South Manchester NHS Trust, North West Lung Centre, Manchester

Liverpool Heart and Chest Hospital, Merseyside

Nottingham University Hospitals NHS Trust, Nottingham

Ruth Children's Hospital Rambam Health Care Campus, Nottingham

B95SS

Birmingham Heartlands Hospital, Birmingham

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03224351 - A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | Biotech Hunter | Biotech Hunter