A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
Public ClinicalTrials.gov record NCT03224351. 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 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
Study identification
- NCT ID
- NCT03224351
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Interventions
- VX-659 Drug
- TEZ/IVA Drug
- IVA Drug
- Placebo (matched to VX-659/TEZ/IVA) Drug
- TEZ Drug
- VX-561 Drug
- Placebo (matched to VX-659/TEZ/VX-561) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Aug 7, 2017
- Primary completion
- Feb 27, 2018
- Completion
- Feb 27, 2018
- Last update posted
- Apr 21, 2021
2017 – 2018
United States locations
- U.S. sites
- 25
- U.S. states
- 17
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | — |
| University of Miami/Miller School of Medicine | Miami | Florida | 33136 | — |
| Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants | Morton Grove | Illinois | 60053 | — |
| Indiana University Health | Indianapolis | Indiana | 46202 | — |
| The University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| The Johns Hopkins Hospital/ Johns Hopkins Hospital, David Rubenstein Child Health Building | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02155 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Helen DeVos Children's Hospital CF Center | Grand Rapids | Michigan | 49503 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Rutgers-Robert Wood Johnson Medical School/ Rutgers-Robert Wood Johnson Medical School, Clinical Research Center | New Brunswick | New Jersey | 08902 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Northwell Health, Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Respiratory Diseases of Children & Adolescents | Oklahoma City | Oklahoma | 73112 | — |
| Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15224 | — |
| Sanford Research / USD | Sioux Falls | South Dakota | 57104 | — |
| University of Tennessee Medical Center-Adult Cystic Fibrosis Clinic | Knoxville | Tennessee | 37920 | — |
| Children's Foundation Research Center / Le Bonheur Children's Hospital | Memphis | Tennessee | 38103 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| University of Utah / Primary Children's Medical Center | Salt Lake City | Utah | 84014 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Providence Pediatric Pulmonary & Allergy/Immunology Clinic | Spokane | Washington | 99204 | — |
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 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03224351, 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 Apr 21, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03224351 live on ClinicalTrials.gov.