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Active, not recruiting Phase 3 Interventional

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

ClinicalTrials.gov ID: NCT05444257

Public ClinicalTrials.gov record NCT05444257. 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 Oct 17, 2026, 8:48 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, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis

Brief summary

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

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

Study identification

NCT ID
NCT05444257
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Enrollment
822 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
Nov 8, 2022 (Actual)
Primary completion
Oct 30, 2026 (Estimated)
Completion
Oct 30, 2026 (Estimated)
Last update posted
Oct 9, 2026

2022 – 2026

United States locations

U.S. sites
72
U.S. states
38
U.S. cities
68
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233 —
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 —
Kaiser Permanente Oakland California 94611 —
University of California Davis Medical Center Sacramento California 95817 —
University of California San Francisco, Lung Transplant Program San Francisco California 94143 —
Children's Hospital of Colorado Aurora Colorado 80045 —
National Jewish Health Denver Colorado 80206 —
University of Florida, Shands Hospital Gainesville Florida 32610 —
Joe DiMaggio Cystic Fibrosis & Pulmonary Center Hollywood Florida 33021 —
University of Miami Miller School of Medicine Miami Florida 33136 —
Central Florida Pulmonary Group,PA Orlando Florida 32803 —
Nemours Children's Specialty Care Pensacola Florida 32514 —
Johns Hopkins All Children's Hospital Outpatient Care Center St. Petersburg Florida 33701 —
The Emory Clinic at Chantilly Atlanta Georgia 30324 —
Augusta University Augusta Georgia 30912 —
St. Luke's Cystic Fibrosis Center of Idaho Boise Idaho 83702 —
Northwestern Memorial Hospital Chicago Illinois 60611 —
Indiana University Indianapolis Indiana 46202 —
Riley Hospital for Children at Indiana University Health Indianapolis Indiana 46202 —
University of Kansas Medical Center Kansas City Kansas 66160 —
University of Kentucky Lexington Kentucky 40508 —
Tulane Medical Center New Orleans Louisiana 70112 —
Maine Medical Partners Portland Maine 04102 —
Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center Boston Massachusetts 02114 —
Boston Children's Hospital Boston Massachusetts 02115 —
UMass Memorial Medical Center Worcester Massachusetts 01655 —
Michigan Medicine Ann Arbor Michigan 48109 —
Harper University Hospital Detroit Michigan 48201 —
Spectrum Health Medical Group Adult Cystic Fibrosis Care Center Grand Rapids Michigan 49546 —
University of Minnesota Minneapolis Minnesota 55455 —
Childrens Hospital University of Missouri Health Sciences Center Columbia Missouri 65212 —
The Children's Mercy Hospital Kansas City Missouri 64108 —
Cardinal Glennon Children's Hospital - St. Louis University St Louis Missouri 63104 —
Washington University School of Medicine / St. Louis Children's Hospital St Louis Missouri 63110 —
Billings Clinic Billings Montana 59101 —
Nebraska Medical Center Omaha Nebraska 68114 —
Dartmouth Hitchcock Manchester New Hampshire 03104 —
Morristown Medical Center Morristown New Jersey 07960 —
Albany Medical College, Pulmonary and Critical Care Medicine Albany New York 12208 —
CF Therapeutics Development Center of Western New York Buffalo New York 14203 —
New York Medical College Hawthorne New York 10532 —
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 —
Atrium Health Levine Children's Hospital Charlotte North Carolina 28207 —
Wake Forest Baptist Health Winston-Salem North Carolina 27104 —
Akron Children's Hospital Akron Ohio 44308 —
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 —
Santiago Reyes, M.D. Oklahoma City Oklahoma 73112 —
Oregon Health & Science University Portland Oregon 97239 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
UPMC Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224 —
Prisma Health Richland Campus Columbia South Carolina 29203 —
Sanford Children's Speciality Clinic Sioux Falls South Dakota 57105 —
University of Tennessee Medical Center Knoxville Tennessee 37920 —
Vanderbilt University Medical Center, Nephrology Clinical Trials Center Nashville Tennessee 37232 —
The University of Texas Southwestern Medical Center Dallas Texas 75390 —
Cook Children's Health Care System Fort Worth Texas 76104 —
Texas Children's Hospital - Baylor College of Medicine Houston Texas 77030 —
University of Utah Salt Lake City Utah 84132 —
Vermont Lung Center Colchester Vermont 05446 —
University of Virginia Health System Charlottesville Virginia 22908 —
University of Washington Medical Center Seattle Washington 98195 —
Providence Pediatric Pulmonary & Cystic Fibrosis Clinic Spokane Washington 99204 —
West Virginia University Morgantown West Virginia 26506 —
University Hospital and UW Health Clinics Madison Wisconsin 53792 —

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 123 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05444257, 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 9, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05444257 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →