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

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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.
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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Minneapolis, MN
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270-05 76th Avenue
New Hyde Park, New York 11040
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New Hyde Park, NY
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