Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
Key facts
- Where
- Gothenburg and Huddinge, SwedenSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 17 years old?
Source: NCT05844449, who can take part
Where in Sweden
- Sahlgrenska University Hospital-Vastra GotalandsregionenGothenburg, SwedenTaking people
- Karolinska University HospitalHuddinge, SwedenTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vertex Pharmaceuticals Incorporated
- Trial code
- NCT05844449EU 2022-503081-74-00
- Record updated
- 29 April 2026
- Original description
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).Read full original descriptionShow less
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Year of Age and Older
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).
Inclusion: 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.
Exclusion: 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.