Summary
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.
Conditions
Cystic Fibrosis
Recruitment Status
Completed
Eligibility Criteria
Key Inclusion Criteria:
Homozygous or heterozygous for F508del mutation (F/F or F/MF genotypes)
Forced expiratory volume in 1 second (FEV1) value ≥40% of predicted mean for age, sex, and height.
Key Exclusion Criteria:
Clinically significant cirrhosis with or without portal hypertension
Lung infection with organisms associated with a more rapid decline in pulmonary status.
Solid organ or hematological transplantation.
Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention
Intervention Type
Intervention Name
Drug
ELX/TEZ/IVA
Drug
IVA
Phase
Phase 3
Gender
All
Min Age
6 Years
Max Age
11 Years
Download Date
October 22, 2021
Principal Investigator
N/A
Primary Contact Information
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: