Restarting Triple Therapy With Robust Monitoring for Adverse Events (RETRIAL)

Recruiting Observational Study
Cystic Fibrosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
6 and older
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Boston Children's Hospital · Other
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About This Trial

RETRIAL is a multi-site observational study of people with Cystic Fibrosis (PWCF) ages 6 and up starting the new triple-therapy modulator (vanzacaftor/tezacaftor/deutivacaftor (VTD)), after having experienced neuropsychiatric events and/or liver injury while taking elexacaftor/tezacaftor/ivacaftor (ETI) that resulted in a modification or discontinuation of standard ETI dosing.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: RETRIAL-Mental Health: * PWCF age 6 years and up (if age is \< 12 years old, the PWCF's caregiver will complete daily diaries and surveys; see "Caregiver Participant Inclusion Criteria" below) * Eligible for VTD and intending to take it * Experienced new or worsening mental hea…
Contacts

Evelyn Bord, BS

617-919-6154

evelyn.bord@childrens.harvard.edu

CONTACT

Callie Bacon, MPH

617-919-7696

callie.bacon@childrens.harvard.edu

CONTACT