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Clinical Trials in Ireland / 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 Ireland tracker
Sponsor
Vertex Pharmaceuticals Incorporated
Phase
Phase 3
Started
2022-11-08
Last updated
2026-09-10

Condition(s) studied

Cystic Fibrosis

Investigational drug(s) / intervention(s)

VX-121/TEZ/D-IVA

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

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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)

Trial sites (195)

FacilityCityRegionStatus
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.

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 Ireland