About the study
A research study about
symptoms, not a new drug
RETRIAL — Restarting Triple Therapy with Robust Monitoring for Adverse Events — is an observational study. We don’t test an experimental medicine. We follow what happens when PWCF start a similar therapy (ALYFTREK — vanzacaftor/tezacaftor/deutivacaftor) after side effects on TRIKAFTA (elexacaftor/tezacaftor/ivacaftor), with extra support from their CF care team.
What the name means
REstarting TRIple Therapy with Robust Monitoring for Adverse Events
“Triple therapy” refers to CFTR modulators that combine three active ingredients — like TRIKAFTA and ALYFTREK.
Why this study matters
TRIKAFTA has helped many people with cystic fibrosis. But some people have had side effects — such as mood changes, anxiety, depression, sleep issues, problems with thinking or memory, or liver problems — and had to change the dose or stop it entirely. Many of these people would like to try the new modulator (ALYFTREK) but wonder if it might cause similar side effects.
RETRIAL helps doctors monitor ALYFTREK side effects. The information we gather can help future patients and their CF care teams make better decisions together.
RETRIAL overview
How the study is organized
Participants take part in the arm(s) that match the side effects they had on TRIKAFTA (elexacaftor / tezacaftor / ivacaftor). Biobank is optional for everyone.
RETRIAL — Mental Health
Mental health & thinking
For people who experienced mental health symptoms (such as mood changes, anxiety, depression, sleep issues, or problems with thinking or memory) on TRIKAFTA.
· Brief online surveys with questions about mood changes, anxiety, depression, sleep issues, or problems with thinking or memory.
RETRIAL – Mental Health
(Optional) Neurocognitive testing
For people ages 7 and up in RETRIAL-Mental Health who also had cognitive symptoms (such as brain fog, or issues with attention, memory, and word finding).
· Two in-person visits to complete a short memory and attention exercise on an iPad (less than 25 minutes).
· Before and after starting ALYFTREK.
RETRIAL — Liver
Liver health
For people with prior liver concerns while on TRIKAFTA. Monthly liver labs required, before and after starting ALYFTREK, as recommended by manufacturer.
· Brief online surveys with questions about your symptoms.
· Monthly liver labs monitored by the doctors (like the medication label requires).
RETRIAL – Biobank
Blood · Stool · Nasal swabs
Choose to share samples to help researchers learn more.
· Available with RETRIAL-Mental Health and RETRIAL-Liver.
Note: RETRIAL observes people starting ALYFTREK (vanzacaftor / tezacaftor / deutivacaftor, ALYFTREK) for the first time. It is not a drug trial — no experimental medication is given. People who have already taken ALYFTREK are not eligible.
Next step
Want to know if RETRIAL might be right for you? Talk to your CF care team.