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Clinical Trial Alerts – November 2020

Cystic Fibrosis Foundation issued the following clinical trial alerts in November.

November 4, 2020

Study to evaluate inhaled AP-PA02 in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (Armata Phase 1b/2 MAD)

Status: Enrolling

Description: This study will look at the safety and tolerability of inhaled AP-PA02, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa to find the best dose.

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 60% or greater

Number of Visits: 10

Length of Participation: 31 days

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04596319

Study to evaluate inhaled AP-PA02 in adults with cystic fibrosis and chronic Pseudomonas aeruginosa (Armata Phase 1b/2 SAD)

Status: Enrolling

Description: This study will look at the safety and tolerability of inhaled AP-PA02, a bacteriophage drug intended to treat infections in the lung. Bacteriophages are specialized viruses that kill very specific bacterial strains. Multiple doses of the drug will be tested in adults with cystic fibrosis and chronic Pseudomonas aeruginosa to find the best dose. 

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 60% or greater

Number of Visits: 8

Length of Participation: 29 days

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04596319

November 5, 2020

Study to evaluate the effects of the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor in children (PROMISE Pediatric Cohort)

Status: Enrolling

Description: This observational study will measure the effects of the triple-combination therapy, elexacaftor/tezacaftor/ivacaftor, in children with CF. These drugs are intended to help CFTR protein function closer to normal. This study will look at how treatment with the triple-combination therapy affects children with CF across many different aspects of the disease. 

Age: 6 Years to 11 Years

Mutation: Two Copies F508del or One Copy F508del

Fev1% Predicted: No FEV1 Limit

Number of Visits: 6

Length of Participation: 2 years

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04613128


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