The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
435
Fixed-dose combination tablets for oral administration.
Fixed-dose combination tablets for oral administration.
Tablet for oral administration.
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1)
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Time frame: From Baseline Through Week 24
Absolute Change in Sweat Chloride (SwCl)
Sweat samples were collected using an approved collection device.
Time frame: From Baseline Through Week 24
Percentage of Participants With SwCl <60 mmol/L (Pooled With Data From Study VX20-121-103)
Sweat samples were collected using an approved collection device.
Time frame: From Baseline Through Week 24
Percentage of Participants With SwCl <30 mmol/L (Pooled With Data From Study VX20-121-103)
Sweat samples were collected using an approved collection device.
Time frame: From Baseline Through Week 24
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Placebo matched to VX-121/TEZ/D-IVA for oral administration.
Placebo matched to ELX/TEZ/IVA for oral administration.
Placebo matched to IVA for oral administration.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner University of Arizona Medical Center
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Miller Children's Hospital / Long Beach Memorial
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Kaiser Permanente
Oakland, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Francisco, Lung Transplant Program
San Francisco, California, United States
Children's Hospital of Colorado
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
...and 129 more locations