Contact CFFC

Mar

Clinical Trial Alerts – March 2020

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

March 4, 2020

ABATE: Study to evaluate IV gallium in adults with cystic fibrosis who have nontuberculous mycobacteria (NTM)

Status: Enrolling

Description: This study is taking place at multiple care centers across the U.S. It will look at the safety and tolerability of IV gallium, a drug intended to treat infections in the lung.

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 25% or greater

Number of Visits: 8

Length of Participation: 20 weeks

ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT04294043

March 6, 2020

Phase 2 study of PTI-428 drug in people with CF ages 18 and older who have two copies of the F508del CFTR mutation

Status: Completed with results

Description: This study evaluated the safety and tolerability of the drug PTI-428. This study was for people with CF ages 18 and older who have two copies of the F508del CFTR mutation and were already taking tezacaftor/ivacaftor (Symdeko®). A key goal of the study was to determine if PTI-428 could increase the amount of CFTR protein produced in people who were already taking tezacaftor/ivacaftor (Symdeko®).

Age: 18 Years and Older

Mutation: Two Copies F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 10

Length of Participation: 74 days

ClincalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03591094

Phase 1b study of inhaled AZD5634 in adults with CF

Status: Completed with results

Description: This study evaluated the safety and tolerability of the inhaled drug AZD5634 in people with CF. It also evaluated the effect of AZD5634 on improving the ability to clear mucus from the lungs (lung mucociliary clearance – MCC).

Age: 18 Years to 60 Years

Mutation: No Mutation Requirement

Fev1% Predicted: 40% or greater

Number of Visits: 4

Length of Participation: 4 months

ClincalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02950805

March 23, 2020

Phase 2 study of PTI-808 triple-combination therapy in adults with cystic fibrosis who have at least one copy of the F508del mutation

Status: Completed with results

Description: This study evaluated the effectiveness and safety of the drug, PTI-808 in combination with PTI-801, with or without PTI-428. This study was for people with CF ages 18 and older who have at least one copy of the F508del CFTR mutation.

Age: 18 Years and Older

Mutation: Two Copies F508del or One Copy F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 9

Length of Participation: 10 weeks

ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/study/NCT03251092


Comments are closed.