Cystic Fibrosis Foundation issued the following clinical trial alerts in December.
December 11, 2019
Status: Completed with results
Description: This study evaluated the effectiveness and safety of the CFTR modulator drug VX-445 (elexacaftor) in combination with ivacaftor and tezacaftor. This triple combination is known as Trikafta™. This study was for people with CF ages 12 and older who have two copies of the F508del CFTR mutation and were already taking tezacaftor plus ivacaftor.
Age: 12 Years and Older
Mutation: Two Copies F508del
Fev1% Predicted: 40 to 90%
Number of Visits: 7
Length of Participation: 10 weeks
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03525548
Status: Completed with results
Description: This study evaluated the effectiveness and safety of the CFTR modulator drug VX-445 (elexacaftor) in combination with tezacaftor and ivacaftor (ELX/TEZ/IVA). This triple combination drug is known as Trikafta™. This study was for people with cystic fibrosis ages 12 and older with one copy of the F508del CFTR mutation and one copy of a minimal function mutation.
Age: 12 Years and Older
Mutation: One Copy F508del
Fev1% Predicted: 40 to 90%
Number of Visits: 10
Length of Participation: 32 weeks
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03525444
Phase 2 study of oral glutathione in children with cystic fibrosis
Status: Completed with results
Description: This study evaluated the safety and effectiveness of the oral glutathione in children with CF who use pancreatic enzyme replacement therapy (PERT).
Age: 24 Months to 10 Years
Mutation: No Mutation Requirement
Fev1% Predicted: No FEV1 Limit
Number of Visits: 4
Length of Participation: 6 months
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03020719
December 17, 2019
Study of ELX-02 in adults with cystic fibrosis who have at least one G542X mutation
Status: Enrolling
Description: This study will look at the safety and tolerability of ELX-02 and how the body processes the drug, a molecule intended to restore CFTR function. Multiple doses of ELX-02 will be tested in adults with cystic fibrosis who have at least one G542X mutation.
Age: 18 Years and Older
Mutation: No Copies F508del
Fev1% Predicted: 40% or greater
Number of Visits: 15
Length of Participation: 15 weeks
ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04135495