Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age

Status:	Recruiting
Conditions:	Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases
Healthy:	No
Age Range:	6 - 11
Updated:	11/4/2018
Start Date:	October 2, 2018
End Date:	January 2020
Contact:	Medical Information
Email:	medicalinfo@vrtx.com
Phone:	6173416777

A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age

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.

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

- Glucose-6-phosphate dehydrogenase (G6PD) deficiency

- 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.

We found this trial at

sites

Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota 55404

from

Minneapolis, MN