A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
Public ClinicalTrials.gov record NCT05033080. 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 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
Study identification
- NCT ID
- NCT05033080
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 435 participants
Conditions and interventions
Conditions
Interventions
- VX-121/TEZ/D-IVA Drug
- ELX/TEZ/IVA Drug
- IVA Drug
- Placebo (matched to VX-121/TEZ/D-IVA) Drug
- Placebo (matched to ELX/TEZ/IVA) Drug
- Placebo (matched to IVA) 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
- Sep 14, 2021 (Actual)
- Primary completion
- May 12, 2023 (Actual)
- Completion
- Nov 21, 2023 (Actual)
- Last update posted
- Oct 3, 2024
2021 – 2023
United States locations
- U.S. sites
- 69
- U.S. states
- 35
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Banner University of Arizona Medical Center | Tucson | Arizona | 85724 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| 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 | — |
| Central Florida Pulmonary Group, PA | Orlando | Florida | 32803 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| 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 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| 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 | 40536 | — |
| Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky | 40202 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center | Boston | Massachusetts | 02114 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Michigan Medicine | Ann Arbor | Michigan | 48109-5212 | — |
| Helen DeVos Children's Hospital CF Center | Grand Rapids | Michigan | 49503 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| 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 | 68198 | — |
| Dartmouth Hitchcock, Manchester | Manchester | New Hampshire | 03104 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| CF Therapeutics Development Center of Western New York | Buffalo | New York | 14203 | — |
| Northwell Health- Long Island Jewish Medical Center | New Hyde Park | New York | 11040 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| New York Medical College | Valhalla | New York | 10595 | — |
| Atrium Health Levine Children's Hospital | Charlotte | North Carolina | 28203 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27104 | — |
| Cleveland Clinic CF | Cleveland | Ohio | 44195 | — |
| 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 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Sanford Children's Speciality Clinic | Sioux Falls | South Dakota | 57105 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Children's Foundation Research Center / Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390-8558 | — |
| Cook Children's Health Care System | Fort Worth | Texas | 76104 | — |
| Texas Children's Hospital - Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Utah - Primary Children's Medical Center | Salt Lake City | Utah | 84132 | — |
| Vermont Lung Center | Colchester | Vermont | 05446 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Inova Fairfax | Falls Church | Virginia | 22042 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| University of Wisconsin Hospital and 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 70 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05033080, 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 3, 2024 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05033080 live on ClinicalTrials.gov.