A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation
Public ClinicalTrials.gov record NCT02725567. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
Study identification
- NCT ID
- NCT02725567
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Month to 24 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2, 2016 (Actual)
- Primary completion
- Jun 28, 2022 (Actual)
- Completion
- Jun 28, 2022 (Actual)
- Last update posted
- Sep 7, 2023
2016 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 13
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Palo Alto | California | — | — |
| Not listed | Atlanta | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Baltimore | Maryland | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Seattle | Washington | — | — |
| Not listed | Madison | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02725567, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 7, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02725567 live on ClinicalTrials.gov.