Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

Plain-language summary

This study evaluates VX-121/Tezacaftor/Deutivacaftor in children aged 1 to 11 with cystic fibrosis. Children with stable disease who have at least one suitable mutation in the CFTR gene (including F508del) may take part. The study is in Phase 3 and is currently active but not recruiting new participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Active, not recruiting

Sponsor

Vertex Pharmaceuticals Incorporated

Intervention

VX-121/TEZ/D-IVA

Start date

6/21/2022

Estimated completion

6/30/2030

Countries

United States, Australia, Canada, France, Germany, Netherlands, New Zealand, Sweden, Switzerland, United Kingdom

Related genes

Locations

• Orange, United States
• Palo Alto, United States
• Aurora, United States
• Atlanta, United States
• Chicago, United States
• Indianapolis, United States
• Boston, United States
• Minneapolis, United States
• Kansas City, United States
• St Louis, United States
• Lake Success, United States
• Cincinnati, United States
• Cleveland, United States
• Columbus, United States
• Portland, United States
• Pittsburgh, United States
• Houston, United States
• Colchester, United States
• Madison, United States
• Nedlands, Australia
• North Adelaide, Australia
• Parkville, Australia
• South Brisbane, Australia
• Toronto, Canada
• Vancouver, Canada
• Bron, France
• Paris, France
• Berlin, Germany
• Essen, Germany
• Hanover, Germany
• Rotterdam, Netherlands
• Grafton, New Zealand
• Gothenburg, Sweden
• Stockholm, Sweden
• Bern, Switzerland
• Zurich, Switzerland
• Cardiff, United Kingdom
• London, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Key Inclusion Criteria:

* Participants with stable CF and at least 1 TCR mutation (including F508del) in the CFTR gene

Key Exclusion Criteria:

* History of solid organ, hematological transplantation, or cancer
* Hepatic cirrhosis with portal hypertension, moderate hepatic impairment (Child Pugh Score 7 to 9), or severe hepatic impairment (Child Pugh Score 10 to 15)
* Lung infection with organisms associated with a more rapid decline in pulmonary status

Other protocol defined Inclusion/Exclusion criteria may apply.