Restarting triple therapy with close monitoring for side effects
Part of Digestive system, Genetic & congenital, Lungs & breathing clinical trials.
This trial tests whether carefully restarting a triple-combination CFTR modulator (VTD) is safe and helpful for people with cystic fibrosis who had to stop or change Trikafta because of mental health side effects or liver injury. You will be closely monitored with surveys and daily diaries to ensure your safety.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are 6 years or older (or have a caregiver who can help if you are under 12).
- You had new or worsening mental health symptoms or a drug-induced liver injury after starting Trikafta (ETI), and that caused you to stop Trikafta, switch to a different modulator, or lower your dose.
- You are planning to start VTD (a newer triple-combination CFTR modulator) and have not taken it before.
- You can delay starting VTD for a short time to complete the initial study surveys.
- You have a smartphone or tablet that can receive survey links, and you can read and answer questions in English.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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