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Clinical Trial Alerts – June 2018

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

The following alert was issued on June 1:

Phase 1 study of PTI-808 drug and triple combination in healthy adults and then in adults with cystic fibrosis

Status: Enrolling

Description: Parts 1 and 2 of this study will take place in healthy volunteers. Part 3 of this study is taking place in adults with cystic fibrosis at multiple care centers across the U.S. It will look at the safety, tolerability, and how the body processes the drug in multiple ascending doses of PTI-808 and PTI-808 together with PTI-428 and PTI-801.

Age: 18 Years and Older

Mutation: Two Copies F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 10

Length of Participation: 56 days

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03251092

The following alerts were issued on June 8:

Phase 3 study of VX-445 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, 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-445 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/NCT03525548

Phase 3 study of VX-445 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-445 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/NCT03525444


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