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Enrolling by invitationPhase 3

Long-term study of vanzacaftor/tezacaftor/deutivacaftor in children with cystic fibrosis

Tests vanzacaftor/tezacaftor/deutivacaftor over time in children with cystic fibrosis.

Key facts

Who runs it
Vertex Pharmaceuticals Incorporated
Where
Bern and Zurich, SwitzerlandSee the 2 sitesAlso in 12 other countries, 39 sites
Registry title
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older
Status
Enrolling by invitation
Phase
Phase 3
People taking part
174 people, planned
Started
11 Aug 2023
Expected to end
30 Jul 2029
Type of study
Interventional
Treatments tested
  • VNZ/TEZ/D-IVA
Record updated
29 April 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Switzerland

Also in 12 other countries, 39 sites

  • Inselspital BernBern, SwitzerlandNo longer taking part
  • Kinderspital Zurich - Abteilung PneumologieZurich, SwitzerlandNo longer taking part

About the trial

What the trial wants to find out

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).

The group in the trial

  • VNZ/TEZ/D-IVATreatment being tested

    Part A: 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. Part B: Participants in Cohort 1 who meet the eligibility criteria will receive VNZ/TEZ/D-IVA for an additional 96 weeks.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Long-term study of vanzacaftor/tezacaftor/deutivacaftor in children with cystic fibrosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05844449, who can take part
Record updated
29 April 2026