A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy

Completed · Phase 3

Conditions studied: Cystic Fibrosis

In brief

The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation

Key facts

Study ID

NCT03525574

Run by

Vertex Pharmaceuticals Incorporated

People needed

507

Starts

2018-10-09

Expected to finish

2023-01-09

Last updated by the study team

2025-09-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed study drug treatment in a parent study i.e.VX17-445-102 (NCT03525444) and VX17-445-103 (NCT03525548); or had study drug interruption(s) in a parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study.

You may not qualify if…

• History of drug intolerance in a parent study that would pose an additional risk to the subject in the opinion of the investigator.
• Current participation in an investigational drug trial (other than a parent study)
• Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Miller Children's Hospital / Long Beach Memorial — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Valley Children's Hospital — Madera, California, United States
• Kaiser Permanente — Oakland, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• UCSF Gateway Medical Center — San Francisco, California, United States
• National Jewish Health — Denver, Colorado, United States
• University of Florida, Shands Hospital — Gainesville, Florida, United States
• Joe DiMaggio Cystic Fibrosis & Pulmonary Center — Hollywood, Florida, United States
• Nemours Children's Specialty Care — Jacksonville, Florida, United States
• Central Florida Pulmonary Group, PA — Orlando, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Tampa General Hospital Cardiac and Lung Transplant Clinic — Tampa, Florida, United States
• Children's Specialty Services at North Druid Hills — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Ann & Robert Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Cystic Fibrosis Center, Children's Hospital of Illinois at OSF Saint Francis Medical Center — Peoria, Illinois, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Maine Medical Partners — Portland, Maine, United States
• Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center — Boston, Massachusetts, United States
• Harper University Hospital — Detroit, Michigan, United States
• Banner University of Arizona Medical Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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