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Study identifier: NCT04183790 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA TC Combination Therapy in Participants With Cystic Fibrosis Who Are 6 Years of Age and Older

Condition: Cystic Fibrosis  ·  Sponsor: Vertex Pharmaceuticals Incorporated

PhasePhase 3
Planned participants64
Who can joinAll sexes, 6 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where21 locations · 5 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

The study evaluates the long-term safety, tolerability, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in participants with cystic fibrosis (CF).

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Key Inclusion Criteria: * Completed study drug treatment in parent study (VX18-445-106 Part B, NCT03691779), or had study drug interruption(s) in parent study but completed study visits up to the last scheduled visit of the Treatment Period in the parent study Key Exclusion Criteria: * History of study drug intolerance in parent study Other protocol defined Inclusion/Exclusion criteria may apply.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (21)

Children's Hospital of Orange CountyOrange, California, United States
Children's Hospital ColoradoAurora, Colorado, United States
Ann & Robert Lurie Children's Hospital of ChicagoChicago, Illinois, United States
Boston Children's HospitalBoston, Massachusetts, United States
Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of MinnesotaMinneapolis, Minnesota, United States
The Children's Mercy HospitalKansas City, Missouri, United States
Northwell Health- Long Island Jewish Medical CenterNew Hyde Park, New York, United States
Clinical Research of CharlotteCharlotte, North Carolina, United States
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical CenterCleveland, Ohio, United States
Nationwide Children's HospitalColumbus, Ohio, United States
Oregon Health & Science UniversityPortland, Oregon, United States
Texas Children's HospitalHouston, Texas, United States

+ 9 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

OrangeAuroraChicagoBoston

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