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Completed Phase 3 Interventional Results available

A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

ClinicalTrials.gov ID: NCT03525548

Public ClinicalTrials.gov record NCT03525548. 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 Jul 21, 2026, 6:42 AM 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-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)

Study identification

NCT ID
NCT03525548
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Vertex Pharmaceuticals Incorporated
Industry
Enrollment
113 participants

Conditions and interventions

Interventions

  • VX-445/TEZ/IVA Drug
  • TEZ/IVA Drug
  • IVA Drug
  • Placebo Drug

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
Aug 2, 2018
Primary completion
Dec 27, 2018
Completion
Dec 27, 2018
Last update posted
Jan 26, 2020

2018

United States locations

U.S. sites
28
U.S. states
19
U.S. cities
27
Facility City State ZIP Site status
Banner University of Arizona Medical Center Tucson Arizona 85724
University of Arkansas for Medical Sciences Little Rock Arkansas 72205
Miller Children's Hospital/ Long Beach Memorial Long Beach California 90806
Children's Hospital Los Angeles Los Angeles California 90027
Valley Children's Hospital Madera California 93636
National Jewish Health Denver Colorado 80206
Joe DiMaggio Cystic Fibrosis & Pulmonary Center/ Joe DiMaggio Children's Hospital/ Memorial Regional Hospital Hollywood Florida 33021
Central Florida Pulmonary Group, PA Orlando Florida 32803
Nemours Children's Hospital Orlando Florida 32827
Tampa General Hospital Cardiac and Lung Transplant Clinic Tampa Florida 33606
Northwestern Memorial Hospital Chicago Illinois 60611
Saint Francis Medical Center/ Children's Hospital of Illinoise/OSF Peoria Illinois 61637
Tulane Medical Center New Orleans Louisiana 70112
Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center Boston Massachusetts 02114
Harper University Hospital Detroit Michigan 48201
New York Medical College Valhalla New York 10595
UNC Marisco Clinical Research Center Chapel Hill North Carolina 27517
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Cleveland Ohio 44106
Nationwide Children's Hospital Columbus Ohio 43205
Dayton Children's Hospital Dayton Ohio 45404
ProMedica Toledo Hospital/ Toledo Children's Hospital/ Pediatric Pulmonary & Cystic Fibrosis Center Toledo Ohio 43606
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Medical University of South Carolina Charleston South Carolina 29425
The University of Texas Southwestern Medical Center Dallas Texas 75390
Vermont Lung Center Colchester Vermont 05446
University of Virginia Primary Care Center Charlottesville Virginia 22908
West Virginia University Morgantown West Virginia 26506

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 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03525548, 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 Jan 26, 2020 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03525548 live on ClinicalTrials.gov.

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