Current Environment:

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

Minimum Age

6 Years

Maximum 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: