The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in participants with CF who are 6 years of age and older with F/MF genotypes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Fixed dose combination (FDC) tablets for oral administration.
Tablet for oral administration.
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Baseline up to Week 100
Absolute Change From Parent Study Baseline in Sweat Chloride (SwCl)
Sweat samples were collected using an approved collection device.
Time frame: From Parent Study Baseline to Week 96
Absolute Change From Parent Study Baseline in Lung Clearance Index 2.5 (LCI2.5)
The LCI2.5 index is the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting values and is calculated by dividing the sum of exhaled tidal breaths (cumulative exhaled volume (CEV)) by simultaneously measured functional residual capacity (FRC). An LCI of 7.5 and below is normal; values greater than 7.5 are abnormal. LCI is able to detect abnormalities in lung function earlier than more traditional modalities such as spirometry.
Time frame: From Parent Study Baseline to Week 96
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Telethon Kids Institute
Nedlands, Australia
Queensland Children's Hospital
South Brisbane, Australia
The Children's Hospital at Westmead
Westmead, Australia
McGill University Health Centre, Glen Site, Montreal Children's Hospital
Montreal, Canada
The Hospital for Sick Children
Toronto, Canada
British Columbia Children's Hospital
Vancouver, Canada
Juliane Marie Center, Rigshospitalet
Copenhagen, Denmark
Groupe Hospitaler Pellegrin, CHU De Bordeaux
Bordeaux, France
CHU Lyon - Hopital Femme Mere-Enfant
Bron, France
Hopital Necker, Enfants Malades
Paris, France
...and 24 more locations