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Clinical Trial Alerts – January 2018

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

These four alerts were distributed on January 22nd.

Phase 3 study of Vertex 661 and ivacaftor in people with CF who have one copy of the F508del-CFTR mutation and a second CFTR mutation predicted to have residual function

Status: Completed with results

Description: This study evaluated the safety and effectiveness of the drug VX-661 in combination with ivacaftor (Kalydeco®) versus ivacaftor alone versus placebo. This study was for people with CF who have one copy of the F508del CFTR mutation and a CFTR mutation associated with residual CFTR function.

Age: 12 Years and Older

Mutation: One Copy F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 12

Length of Participation: 33 weeks

ClincalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT02392234

Phase 3 study of lumacaftor and ivacaftor in with cystic fibrosis with advanced lung disease

Status: Completed with results

Description: This study evaluated the safety of the drugs lumacaftor and ivacaftor (Orkambi®). This study was for people with CF who have two copies of the F508del CFTR mutation and have advanced lung disease.

Age: 12 Years and Older

Mutation: Two Copies F508del

Fev1% Predicted: Less than 40%

Number of Visits: 14

Length of Participation: 52 weeks

ClincalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02390219

Phase 3 study of VX-661 and ivacaftor in people with cystic fibrosis

Status: Completed with results

Description: This study evaluated the safety and effectiveness of the drug VX-661 in combination with ivacaftor (Kalydeco®) compared with placebo. This study was for people with CF who have two copies of the F508del CFTR mutation.

Age: 12 Years and Older

Mutation: Two Copies F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 11

Length of Participation: 32 weeks

ClincalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT02347657

VX-661 alone and in combination with ivacaftor in people with cystic fibrosis

Status: Completed with results

Description: This study looked at the safety and effectiveness of multiple dose levels of VX-661 alone and in combination with ivacaftor (Kalydeco®).

Age: 18 Years and Older

Mutation: Two Copies F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 9

Length of Participation: 84 days

ClincalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT01531673


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