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Clinical Trial Alerts – January 2019

Cystic Fibrosis Foundation distributed the following clinical trial updates in January. Click the trial title to get more details.

January 8, 2019

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

Status: Completed with Results

Description: This study evaluated the safety, tolerability and effectiveness of the drug VX-445 in combination with tezacaftor/ivacaftor (Symdeko®) in people who either have two copies of the F508del CFTR mutation or have one copy of F508del and one copy of a minimal function CFTR mutation.

Age: 18 Years and Older

Mutation: Two Copies F508del or One Copy F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 6

Length of Participation: 12 weeks

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

 SOLUTION: Study of Liprotamase in people with CF

Status: Completed with Results

Description: This study evaluated the safety and effectiveness of the drug liprotamase in people with CF who were taking digestive enzymes.

Age: 7 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 30% or greater

Number of Visits: 10

Length of Participation: 28 weeks

ClinicalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT02279498

Persistent Methicillin Resistant Staphylococcus Aureus (MRSA) Growth in Respiratory Culture

Status: Completed with Results

Description: This study evaluated the safety and effectiveness of inhaled vancomycin to eliminate the bacterium, methicillin-resistant Staphylococcus aureus (MRSA) in people with CF who have persistent MRSA infection.

Age: 12 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40% or greater

Number of Visits: 7

Length of Participation: 8 months

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT01594827

January 24, 2019

Study of SPI-1005 in people with CF ages 18 and older

Status: Enrolling

Description: This study will test the safety and tolerability of SPI-1005, a drug intended to prevent and treat hearing loss caused by aminoglycosides.

Age: 18 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 40 to 100%

Number of Visits: 6

Length of Participation: 49 days

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02819856

January 25, 2019

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

Status: Completed with Results

Description: This study evaluated the safety, tolerability and effectiveness of the drug VX-659 in combination with tezacaftor/ivacaftor (Symdeko®) in people who either have two copies of the F508del CFTR mutation or have one copy of F508del and one copy of a minimal function CFTR mutation.

Age: 18 Years and Older

Mutation: Two Copies F508del or One Copy F508del

Fev1% Predicted: 40% or greater

Number of Visits: 6

Length of Participation: 8 weeks

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

PROSPECT Part A

Status: Completed with Results

Description: Part A of the PROSPECT study identified biomarkers of CFTR function that could be used to monitor disease progression.

Age: 6 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 3

Length of Participation: 3 months

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT02477319

PROSPECT Part B

Status: Completed with Results

Description: Part B of the PROSPECT study evaluated the effectiveness of lumacaftor/ivacaftor (Orkambi®) and collected biospecimens and clinical data from people who have two copies of the F508del CFTR mutation both before and after treatment with lumacaftor/ivacaftor.

Age: 12 Years and Older

Mutation: Two Copies F508del

Fev1% Predicted: No FEV1 Limit

Number of Visits: 5

Length of Participation: 1 years

ClinicalTrials.gov link: [None provided]


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