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Completed Phase 3 Interventional Results available

A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

ClinicalTrials.gov ID: NCT03460990

Public ClinicalTrials.gov record NCT03460990. 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.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:59 PM EDT

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, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).

Study identification

NCT ID
NCT03460990
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
116 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 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
Apr 30, 2018
Primary completion
Sep 25, 2018
Completion
Oct 7, 2018
Last update posted
Oct 16, 2019

2018

United States locations

U.S. sites
28
U.S. states
22
U.S. cities
28
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233
Yale New Haven Medical Center New Haven Connecticut 06511
University of Miami/Miller School of Medicine Miami Florida 33136
St. Luke's CF Center of Idaho Boise Idaho 83712
Advocate Children's Hospital- Park Ridge/ North Suburban Pulmonary and Critical Care Consultants Niles Illinois 60714
Indiana Clinical Research Center, IU Health University Hospital Indianapolis Indiana 46202
The University of Iowa Hospitals and Clinics Iowa City Iowa 52242
The Johns Hopkins Hospital Baltimore Maryland 21287
Boston Children's Hospital Boston Massachusetts 02115
Helen DeVos Children's Hospital CF Center Grand Rapids Michigan 49503
Children's Mercy Hospital Kansas City Missouri 64108
Washington University School of Medicine / St. Louis Children's Hospital St Louis Missouri 63110
Rutgers-Robert Wood Johnson Medical School New Brunswick New Jersey 08901
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
Cincinnati Children's Hospital Medical Center Cincinnati Ohio 45229
Respiratory Diseases of Children and Adolescents Oklahoma City Oklahoma 73211
Oregon Health & Science University Portland Oregon 97239
Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center Pittsburgh Pennsylvania 15224
Sanford Research/ USD Sioux Falls South Dakota 57105
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
Baylor College of Medicine Houston Texas 77030
University of Utah/ Primary Children's Medical Center Salt Lake City Utah 84132
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 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03460990, 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 16, 2019 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03460990 live on ClinicalTrials.gov.

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