Liver arm
You may be eligible if…
- Had a history of liver concerns while on TRIKAFTA
- Starting ALYFTREK for the first time
Liver arm
For people with prior liver concerns on TRIKAFTA
The RETRIAL Liver arm is open to PWCF who had liver concerns while taking TRIKAFTA (elexacaftor / tezacaftor / ivacaftor) and are now starting ALYFTREK (vanzacaftor / tezacaftor / deutivacaftor) for the first time.
Shared eligibility
Everyone in RETRIAL meets these baseline criteria.
PWCF ages 6 and older
Planning to start ALYFTREK for the first time with your CF care team
Optional biobanking is available alongside this arm.
- Requires an in-person visit.
This study may not be a fit for…
- People who are pregnant or breastfeeding
- People on the transplant list, or within 3 months after a transplant
- People who had a liver transplant
- People with severe (decompensated) liver disease
- People who cannot access ALYFTREK
- People who have already taken ALYFTREK — RETRIAL only follows people starting it for the first time
Each CF center has its own process for review. Your CF care team is the best resource to help decide if the study is right for you. They can also connect you with a participating site.
What to expect
Participation is voluntary. You can ask questions at any time, and you can stop at any time. See the FAQ section for additional information.
Step 1
Talk with your CF care team
Your CF doctor or coordinator will explain the study and answer any questions before you decide.
Step 2
Surveys before you start ALYFTREK and every 3 months after
Brief online surveys with questions about your symptoms. Most take just a few minutes
Step 3
Liver function monitoring
ALYFTREK box label recommends liver tests before and monthly after starting ALYFTREK to monitor liver function. RETRIAL requires these labs. If done as recommended, no additional tests for research are needed.
Optional
Optional samples (Biobank)
Requires an in-person visit. You may choose to share blood, stool, AND/OR nasal swab samples to help researchers learn more.