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COMPLETEDPHASE3

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

A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation

NCT03525574•Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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)

Locations (110)

Banner University of Arizona Medical Center

Tucson, Arizona, United States

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

Key Dates

Start Date

October 9, 2018

Primary Completion Date

January 9, 2023

Completion Date

January 9, 2023

Last Updated

September 24, 2025

Enrollment

507

ACTUAL participants

Conditions

Cystic Fibrosis

Interventions

ELX/TEZ/IVA

DRUG

IVA

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

View study

RECRUITINGNA

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT06616857

Cystic Fibrosis (CF)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

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