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Clinical Trial Alerts – December 2019

Cystic Fibrosis Foundation issued the following clinical trial alerts in December.

December 11, 2019

Study of VX-445 plus ivacaftor and tezacaftor in people with CF who have two copies of the F508del CFTR mutation

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

Study of effectiveness and safety of elexacaftor/tezacaftor/ivacaftor in people with CF who have one copy of the F508del CFTR mutation

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


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