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Clinical Trial Alerts – January 2019

Cystic Fibrosis Foundation distributed the following clinical trial updates in January. Click the trial title to get more details.

January 8, 2019

Phase 1/2 study of VX-445 combination drug in healthy adults and then in people with cystic fibrosis

Status: Completed with Results

Description: This study evaluated the safety, tolerability and effectiveness of the drug VX-445 in combination with tezacaftor/ivacaftor (Symdeko®) in people who either have two copies of the F508del CFTR mutation or have one copy of F508del and one copy of a minimal function CFTR mutation.

Age: 18 Years and Older

Mutation: Two Copies F508del or One Copy F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 6

Length of Participation: 12 weeks

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03227471

 SOLUTION: Study of Liprotamase in people with CF

Status: Completed with Results

Description: This study evaluated the safety and effectiveness of the drug liprotamase in people with CF who were taking digestive enzymes.

Age: 7 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 30% or greater

Number of Visits: 10

Length of Participation: 28 weeks

ClinicalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT02279498

Persistent Methicillin Resistant Staphylococcus Aureus (MRSA) Growth in Respiratory Culture

Status: Completed with Results

Description: This study evaluated the safety and effectiveness of inhaled vancomycin to eliminate the bacterium, methicillin-resistant Staphylococcus aureus (MRSA) in people with CF who have persistent MRSA infection.

Age: 12 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40% or greater

Number of Visits: 7

Length of Participation: 8 months

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT01594827


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