Overview

Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age

Status:
Terminated
Trial end date:
2019-01-18
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes. The study was discontinued after completion of Part A due to Sponsor's discretion.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Treatments:
Ivacaftor
VX-659
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.