Summary
The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Conditions
Cystic Fibrosis
Recruitment Status
RECRUITING
Eligibility Criteria
Key Inclusion Criteria:
* Participants with stable CF and at least 1 TCR mutation (including F508del) in the CFTR gene
Key Exclusion Criteria:
* History of solid organ, hematological transplantation, or cancer
* Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
* Lung infection with organisms associated with a more rapid decline in pulmonary status
Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention
Intervention Type
Intervention Name
DRUG
VX-121/TEZ/D-IVA
Phase
PHASE3
Gender
ALL
Min Age
1 Year
Max Age
11 Years
Download Date
2024-07-01
Principal Investigator
N/A
Primary Contact Information
robert.fowler@childrens.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: