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

Stopped early · Phase 3

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT03633526

Run by

Vertex Pharmaceuticals Incorporated

People needed

18

Starts

2018-08-03

Expected to finish

2019-01-18

Last updated by the study team

2020-02-05

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• The Children's Mercy Hospital — Kansas City, Missouri, United States
• Clinical Research of Charlotte — Charlotte, North Carolina, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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