Long-term study of vanzacaftor/tezacaftor/deutivacaftor in children with cystic fibrosis
Tests vanzacaftor/tezacaftor/deutivacaftor over time in children with cystic fibrosis.
Plain-language title generated from the registry record
Registry title: Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
Key facts
- Where
- Berlin, Essen, and Hanover, GermanySee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with cystic fibrosis who finished treatment in the earlier study VX21-121-105 (NCT05422222). It tests the long-term safety and effect of VNZ/TEZ/D-IVA.
- Age
- 1 year to 17 years
- Sex
- All sexes can join.
- Disease stage
- Cystic fibrosis. No stage or severity is named.
- Earlier treatment
- People must have finished study drug treatment in the earlier study VX21-121-105. For Part B, people must have finished treatment in Part A, or had breaks in Part A without stopping the drug for good.
Main reasons for not taking part
- Liver cirrhosis with portal hypertension, or moderate or severe liver impairment that could add risk
- A history of solid organ or blood-related transplant, or cancer
- A history of not tolerating the drug in the earlier study
Read by machine on 9 November 2026.
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 Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Medizinische Hochschule Hannover Service GmbHHanover, GermanyTaking 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.