A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis

PHASE2CompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

April 30, 2019

Primary Completion Date

December 10, 2019

Study Completion Date

December 10, 2019

Conditions
Cystic Fibrosis
Interventions
DRUG

VX-121

Tablets for oral administration.

DRUG

TEZ

TEZ tablet for oral administration.

DRUG

VX-561

Tablets for oral administration.

DRUG

TEZ/IVA

Fixed-dose combination tablets for oral administration.

DRUG

IVA

Tablets for oral administration.

DRUG

Placebo

Placebos matched to VX-121, TEZ, and VX-561 for oral administration.

Trial Locations (26)

10032

Columbia University Medical Center, New York

27157

Wake Forest University Baptist Medical Center, Winston-Salem

37232

Vanderbilt University Medical Center, Nashville

40536

University of Kentucky., Lexington

43205

Nationwide Children's Hospital, Columbus

55455

University of Minnesota, Minneapolis

70112

Tulane Medical Center, New Orleans

73112

Santiago Reyes, M.D., Oklahoma City

90033

Keck Medical Center of University of Southern California, Los Angeles

94611

Kaiser Permanente, Oakland

02115

Boston Children's Hospital, Boston

78229-3900

University of Texas Health Science Center at San Antonio, San Antonio

Unknown

Charite Paediatric Pulmonology Department, Berlin

Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen, Essen

Pneumologisches Studienzentrum Muenchen-West, München

Academic Medical Center, Amsterdam

University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis, Heidelberglaan

UMC St. Radboud, Nijmegen

Erasmus Medical Center, Rotterdam

HagaZiekenhuis van den Haag, The Hague

Hospital de Santa Maria, Lisbon

University Hospitals Birmingham NHS Foundation Trust, Birmingham

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

Wythenshawe Hospital, Manchester

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

All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough, Penarth

All Listed Sponsors
lead

Vertex Pharmaceuticals Incorporated

INDUSTRY

NCT03912233 - A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | Biotech Hunter | Biotech Hunter