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Clinical Trial Alerts – March 2018

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

The following alert was issued on March 1:

Phase 3 study of VX-659 triple combination drug in people with CF 12 years and older who have one copy of the F508del mutation and one copy of a minimal function mutation

Status: Enrolling

Description: This randomized, placebo-controlled study will be taking place at multiple care centers across the U.S. It will evaluate the effectiveness, safety, and effect on the body of the drug VX-659 in combination with tezacaftor and ivacaftor. It is 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/NCT03447249

The following alerts were issued on March 8:

PREDICT: NTM observational study

Status: Enrolling

Description: This study is taking place at multiple care centers across the U.S. It will evaluate the current standard of diagnosing nontuberculous mycobacteria (NTM) in people with CF.

Age: 10 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 20

Length of Participation: 5 years

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02073409

RESTORE-CF: Phase 1/2 study of MRT5005 drug in adults with cystic fibrosis

Status: Enrolling

Description: This first-in-human study is taking place at multiple care centers across the U.S. It will look at the safety and tolerability of different doses of the nebulized drug MRT5005 in adults with CF.

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 50 to 90%

Number of Visits: 17

Length of Participation: 4 months

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03375047

The following alerts were issued on March 9:

Phase 3 study of VX-659 triple combination drug in people with CF ages 12 years and older who have two copies of the F508del mutation

Status: Enrolling

Description: This randomized, placebo-controlled study is taking place at multiple care centers across the U.S. It will look at the effectiveness and safety of the drug VX-659 in combination with ivacaftor and tezacaftor. It is for people with CF ages 12 and older 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: 7

Length of Participation: 10 weeks

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03460990

Phase 2 study of lenabasum in people with CF ages 12 and older

Status: Enrolling

Description: This study is taking place at multiple care centers across the U.S. It will look at the safety and effectiveness of the potential anti-inflammatory drug lenabasum and will use a placebo control.

Age: 12 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40 to 100%

Number of Visits: 10

Length of Participation: 32 weeks

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03451045


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