Clinical Trials in Denmark / NCT05444257
Active, not recruiting
Phase 3
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
NCT05444257 · tracked via the Priya Life Science Denmark tracker
Condition(s) studied
Cystic Fibrosis
Investigational drug(s) / intervention(s)
VX-121/TEZ/D-IVA: Fixed-dose combination tablets for oral administration.
Study summary
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.
Eligibility
Key Inclusion Criteria:
* Part A: Completed study drug treatment in a parent study VX20-121-102 (NCT05033080) and VX20-121-103 (NCT05076149); or had study drug interruption(s) in a parent study but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period in the parent study
* Part B: Completed study drug treatment in Part A; or had study drug interruption(s) in Part A, but did not permanently discontinue study drug, and completed study visits up to the last scheduled visit of the Treatment Period of Part A
Key Exclusion Criteria:
* History of drug intolerance in a parent study
* Pregnant or breast-feeding females at the time of enrollment in Part A
Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — From Baseline up to Week 148
Trial sites (195)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Banner University of Arizona Medical Center | Tucson | Arizona | |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | |
| Miller Children's Hospital / Long Beach Memorial | Long Beach | California | |
| Children's Hospital Los Angeles | Los Angeles | California | |
| Kaiser Permanente | Oakland | California | |
| University of California Davis Medical Center | Sacramento | California | |
| University of California San Francisco, Lung Transplant Program | San Francisco | California | |
| Children's Hospital of Colorado | Aurora | Colorado | |
| National Jewish Health | Denver | Colorado | |
| University of Florida, Shands Hospital | Gainesville | Florida | |
| Joe DiMaggio Cystic Fibrosis & Pulmonary Center | Hollywood | Florida | |
| University of Miami Miller School of Medicine | Miami | Florida | |
| Central Florida Pulmonary Group,PA | Orlando | Florida | |
| Nemours Children's Specialty Care | Pensacola | Florida | |
| Johns Hopkins All Children's Hospital Outpatient Care Center | St. Petersburg | Florida | |
| The Emory Clinic at Chantilly | Atlanta | Georgia | |
| Augusta University | Augusta | Georgia | |
| St. Luke's Cystic Fibrosis Center of Idaho | Boise | Idaho | |
| Northwestern Memorial Hospital | Chicago | Illinois | |
| Indiana University | Indianapolis | Indiana | |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| University of Kentucky | Lexington | Kentucky | |
| Tulane Medical Center | New Orleans | Louisiana | |
| Maine Medical Partners | Portland | Maine | |
| Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center | Boston | Massachusetts | |
| Boston Children's Hospital | Boston | Massachusetts | |
| UMass Memorial Medical Center | Worcester | Massachusetts | |
| Michigan Medicine | Ann Arbor | Michigan | |
| Harper University Hospital | Detroit | Michigan | |
| Spectrum Health Medical Group Adult Cystic Fibrosis Care Center | Grand Rapids | Michigan | |
| University of Minnesota | Minneapolis | Minnesota | |
| Childrens Hospital University of Missouri Health Sciences Center | Columbia | Missouri | |
| The Children's Mercy Hospital | Kansas City | Missouri | |
| Cardinal Glennon Children's Hospital - St. Louis University | St Louis | Missouri | |
| Washington University School of Medicine / St. Louis Children's Hospital | St Louis | Missouri | |
| Billings Clinic | Billings | Montana | |
| Nebraska Medical Center | Omaha | Nebraska | |
| Dartmouth Hitchcock | Manchester | New Hampshire |
+ 155 more sites — see the full list on the official registry below.
More Vertex Pharmaceuticals Incorporated trials in Denmark
Other trials for the same condition
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
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Cardiac Structure and Function in Patients with Cystic Fibrosis
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05444257 on ClinicalTrials.gov ↗ ← All trials in Denmark