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Clinical Trial Alerts – April 2021

Cystic Fibrosis Foundation issued the following clinical trial alerts in April

April 13, 2021

OPTION: Study of AzurRx MS1819 in people with cystic fibrosis (CF) and exocrine pancreatic insufficiency who are 18 years and older

Status: Completed with results

Description: This study evaluated the safety and effectiveness of the drug MS1819 as a pancreatic enzyme replacement therapy (PERT). MS1819 is a non-porcine (not pig-derived) lipase-only enzyme for people with CF who have exocrine pancreatic insufficiency (EPI).

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 30% or greater

Number of Visits: 10

Length of Participation: 11 weeks

ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT03746483

April 14, 2021

HERO-2

Status: Enrolling

Description: This study will collect everyday observations that individuals with CF, who are taking the triple-combination modulator, elexacaftor/tezacaftor/ivacaftor (Trikafta®), make in their daily lives over 12 months. Participants will use the Folia app to track their routine treatments, medication usage, and symptoms, and will answer validated patient-reported outcome questionnaires. Participants who are participating in the CF Patient Registry will have their Registry data linked to their Folia tracking data to assess the relationship between any medication changes and changes in lung function. This study will not provide or make any treatment recommendations, and there are no required study visits. 

Age: 12 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 0

Length of Participation: 12 months

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04798014


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