This study is currently not recruiting participants.

A Phase 3 2-Arm Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation

Study on the Safety and Effects of an Investigational Medication in Young Children with Cystic Fibrosis

Not Recruiting
2 years - 5 years
All
Phase N/A
1 Location

Brief description of study.

The study is being done to learn more about the safety and effects ivacaftor has on children aged 2 through 5 years with Cystic Fibrosis.

Detailed description of study

The study is being done to learn more about the safety and effects ivacaftor has on children aged 2 through 5 years with Cystic Fibrosis.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Cystic Fibrosis
  • Age: 2 years - 5 years
  • Gender: All

The purpose of this study is to investigate the safety and effects of an investigational medication in children aged 2 through 5 years who have Cystic Fibrosis. Cystic Fibrosis is a genetic condition that affects the lungs and digestive system, leading to severe respiratory and digestive problems.

Participants in the study will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will monitor the children's health and any side effects they may experience.

  • Who can participate: Children aged 2 through 5 years diagnosed with Cystic Fibrosis are eligible to participate in this study.
  • Study details: Participants will receive either the investigational medication or a placebo.
Updated on 19 Feb 2024. Study ID: 1306011557

Interested in the study?

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