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Sep

Clinical Trial Alerts – September 2020

Cystic Fibrosis Foundation issued the following clinical trial alerts in the month of September.

September 8, 2020

Study to evaluate the effects of CFTR modulators in infants and young children (BEGIN Part A)

Status: Enrolling

Description: This two-part observational study will look at the effects of CFTR modulators on growth in young children with CF. These drugs are intended to help CFTR protein function closer to normal.

Age: 0 Years to 4 Years

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 6

Length of Participation: 3 years

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04509050

Study to evaluate the effects of CFTR modulators in infants and young children (BEGIN Part B)

Status: Enrolling

Description: This two-part observational study will look at the effects of CFTR modulators on growth in young children with CF. These drugs are intended to help CFTR protein function closer to normal.

Age: Less than 6 Years

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 6

Length of Participation: 2 years

ClinicalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT04509050

September 30, 2020

Study of VX-445 Triple Combination in Teens and Adults With Cystic Fibrosis (CF) Who Have One Copy of F508del and One Copy of a Gating or Residual Function Mutation

Status: Completed with results

Description: This study evaluated the safety and effectiveness of VX-445 (elexacaftor), tezacaftor, and ivacaftor in combination called TRIKAFTA®. This study was for people with CF 12 years and older with one copy of the F508del mutation and one copy of a gating or residual function mutation.

Age: 12 Years and Older

Mutation: One Copy F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 8

Length of Participation: 20 weeks

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT04058353


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