Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
Cystic Fibrosis
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Key Inclusion Criteria: Participants who have completed study drug treatment in the parent study (VX21-121-105; NCT Number: NCT05422222) Key Exclusion Criteria: Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe hepatic impairment that might pose an additional risk in administering study drug History of solid organ, hematological transplantation, or cancer History of drug intolerance in the parent study Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Children's Hospital of Orange County
- Children's Hospital of Colorado
- The Emory Clinic / Children's Healthcare of Atlanta at Egleston
- Ann & Robert H. Lurie Children's Hospital of Chicago
- Riley Hospital for Children at Indiana University Health
- Boston Children's Hospital
- Children's Respiratory and Critical Care Specialists, P.A., Children's Hospitals and Clinics of Minnesota
- The Children's Mercy Hospital
- Washington University School of Medicine / St. Louis Children's Hospital
- Cohen Children's Medical Center
- Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
- Nationwide Children's Hospital
- UPMC Children's Hospital of Pittsburgh
- Vermont Lung Center
- The Royal Childrens Hospital
- Queensland Children's Hospital
- CHU Lyon - Hopital Femme Mere-Enfant
- Hopital Necker, Enfants Malades
- Charite Paediatric Pulmonology Department
- Kinderklinik III, Abt. fur Pneumologie
- Medizinische Hochschule Hannover
- Erasmus Medical Center / Sophia Children's Hospital
- Sahlgrenska Universitetssjukhuset
- Inselspital - Universitaetsspital Bern
- Kinderspital Zuerich
- Children and Young Adults Research Unit
Arms of the Study
Arm 1
Experimental
VNZ/TEZ/D-IVA
Participants (Cohort 1: 6 through 11 years of age (inclusive); Cohort 2: 2 through 5 years of age (inclusive) and Cohort 3: 1 to less than (<) 2 years of age) will receive VNZ/TEZ/D-IVA once daily at doses determined based on their age and weight. The age range is based on date of informed consent in parent study.