Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Public ClinicalTrials.gov record NCT03691779. 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.
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Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03691779
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 71 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 11 Years
- 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
- Oct 2, 2018 (Actual)
- Primary completion
- Aug 7, 2020 (Actual)
- Completion
- Aug 7, 2020 (Actual)
- Last update posted
- Oct 22, 2021
2018 – 2020
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Ann & Robert Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | 55404 | — |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Northwell Health- Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| Clinical Research of Charlotte | Charlotte | North Carolina | 28277 | — |
| Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
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 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03691779, 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 Oct 22, 2021 · Synced Nov 7, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03691779 live on ClinicalTrials.gov.