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Clinical Trial Alerts – July 2017

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

Two alerts were issued on July 28, 2017:

Phase 2 study of VX-659 combination drug in adults with cystic fibrosis

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 drug VX-659.

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40% or greater

Number of Visits: 6

Length of Participation: 8 weeks

ClinicalTrials.gov link:https://clinicaltrials.gov/ct2/show/NCT03224351

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

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 drug VX-445.

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40 to 90%

Number of Visits: 6

Length of Participation: 12 weeks

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

One alert were issued on July 19, 2017:

RESULT: Study of liprotamase non-porcine enzymes

Status: Enrolling

Description: This randomized, parallel-assignment study is taking place at multiple care centers across the U.S. It will look at the effectiveness of liprotamase, a non-pig-derived pancreatic enzyme replacement therapy (PERT), as compared to a pig-derived PERT.

Age: 7 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 17

Length of Participation: 30 weeks

ClinicalTrials.gov Link: https://www.clinicaltrials.gov/ct2/show/NCT03051490

Three alerts were issued on July 11, 2017:

Phase 1b study of inhaled AZD5634 in adults with CF

Status: Enrolling

Description: This study is taking place at multiple care centers across the US. It will look at the safety and tolerability of the inhaled drug AZD5634 and will use a placebo control.

Age: 18 Years to 60 Years

Mutation: No Mutation Requirement

Fev1% Predicted: 40% or greater

Number of Visits: 4

Length of Participation: 4 months

ClinicalTrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT02950805

STOP: Standardized Treatment of Pulmonary Exacerbations Pilot Study

Status: Competed with results

Description: This study evaluated current physician treatment practices and patient outcomes for the management of pulmonary exacerbations (PEx). The goal was to collect this information so that it could later inform a future study of treatments of PEx.

Age: 12 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 4

Length of Participation: 28 days

ClinicalTrials.gov Link: N/A

Study of in-line digestive enzyme cartridge (Relizorb) in people with CF who are currently receiving enteral tube feedings

Status: Competed with results

Description: This study looked at the safety and effectiveness of Relizorb®, a new digestive enzyme cartridge designed for people with pancreatic insufficiency (PI) that can be used in-line with enteral tube feeding. This cartridge delivers the digestive enzyme lipase, which helps the body digest fats contained in the tube-feeding formula.

Age: 4 Years to 82 Years

Mutation: No Mutation Requirement

Fev1% Predicted: Less than 100%

Number of Visits: 4

Length of Participation: 27 days

ClinicalTrials.gov Link:https://www.clinicaltrials.gov/ct2/show/NCT02598128


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