Clinical Trials in Sweden / NCT05844449
Enrolling by invitation
Phase 3
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
NCT05844449 · tracked via the Priya Life Science Sweden tracker
Condition(s) studied
Cystic Fibrosis
Investigational drug(s) / intervention(s)
VNZ/TEZ/D-IVA: Fixed-dose combination tablets or granules for oral administration.
Study summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).
Eligibility
Key Inclusion Criteria:
Parts A and B:
• Participants who have completed study drug treatment in the parent study (VX21-121-105; NCT Number: NCT05422222)
Part B:
-Meets at least 1 of the following criteria:
* Completed study drug treatment in Part A
* Had study drug interruption(s) in Part A, but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the treatment period of Part A
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.
Primary outcome measure(s)
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) — From Baseline up to Week 100
- Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) — From Baseline up to Week 196
Trial sites (37)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital of Orange County | Orange | California | |
| Stanford University - Palo Alto - Pulmonology | Palo Alto | California | |
| Children's Hospital of Colorado - Pulmonology | Aurora | Colorado | |
| The Emory Clinic - Clifton Road - Pulmonology | Atlanta | Georgia | |
| Ann & Robert H. Lurie Children's Hospital of Chicago - Hematology | Chicago | Illinois | |
| JW Riley Hospital for Children - Pulmonology | Indianapolis | Indiana | |
| Boston Children's Hospital | Boston | Massachusetts | |
| Children's Health Care d/b/a Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota | |
| The Children's Mercy Hospital | Kansas City | Missouri | |
| St. Louis Children's Hospital - Pulmonology | St Louis | Missouri | |
| Cohen Children's Medical Center - Lakeville Road | Lake Success | New York | |
| Cincinnati Children's Hospital Medical Center - Pulmonology | Cincinnati | Ohio | |
| UH Cleveland Medical Center - Pulmonology | Cleveland | Ohio | |
| Nationwide Children's Hospital | Columbus | Ohio | |
| Children's Hospital of Pittsburgh - Pulmonology | Pittsburgh | Pennsylvania | |
| Texas Children's Hospital - Wallace Tower - Pulmonology | Houston | Texas | |
| Vermont Lung Center | Colchester | Vermont | |
| American Family Childrens Hospital | Madison | Wisconsin | |
| The Kids Research Institute Australia | Nedlands | Australia | |
| Women's & Children's Hospital | North Adelaide | Australia | |
| The Royal Children's Hospital Melbourne | Parkville | Australia | |
| Children's Health Queensland Hospital and Health Service | South Brisbane | Australia | |
| Hospital for Sick Children - Pulmonology | Toronto | Canada | |
| British Columbia Children's Hospital | Vancouver | Canada | |
| Hopital Femme Mere-Enfant | Bron | France | |
| Hopital Necker Enfants Malades - Pulmonology | Paris | France | |
| Charite Paediatric Pulmonology Department | Berlin | Germany | |
| Universitatsklinikum Essen | Essen | Germany | |
| Medizinische Hochschule Hannover - Clinic for Pediatric Pneumology, Allergology and Neonatology, CF-Centre | Hanover | Germany | |
| Sophia Children's Hospital | Rotterdam | Netherlands | |
| Starship Child Health | Grafton | New Zealand | |
| Sahlgrenska Universitetssjukhuset - Göteborg CF-center | Gothenburg | Sweden | |
| Karolinska University Hospital - Pulmonology | Stockholm | Sweden | |
| Inselspital Bern | Bern | Switzerland | |
| Kinderspital Zurich - Abteilung Pneumologie | Zurich | Switzerland | |
| Noah's Ark Children's Hospital for Wales | Cardiff | United Kingdom | |
| Great Ormond Street Hospital for Children | London | United Kingdom |
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Other trials for the same condition
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del
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A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
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Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
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CFTR Modulators in Pregnancy and Postpartum
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A Phase 1/2 Study of VX-522 in Participants With Cystic Fibrosis (CF)
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05844449 on ClinicalTrials.gov ↗ ← All trials in Sweden