Clinical Trial Alerts – June 2019

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

June 10, 2019

Study of ABBV-3067 and ABBV-2222 in adults with cystic fibrosis who have two copies of the F508del mutation

Status: Enrolling

Description: This study will look at the safety and effectiveness of ABBV-3067, a CFTR modulator intended to help CFTR protein function closer to normal. ABBV-3067 will be tested alone and in combination with another CFTR modulator, ABBV-2222.

Age: 18 Years and Older

Mutation: Two Copies F508del

Fev1% Predicted: 40 to 90%

Number of Visits: 5

Length of Participation: 3 months

ClinicalTrials.gov link: https://clinicaltrials.gov/ct2/show/NCT03969888

June 11, 2019

RESULT: Study of liprotamase non-porcine enzymes

Status: Completed

Description: This study evaluated the effectiveness of liprotamase, a non-pig-derived pancreatic enzyme replacement therapy (PERT), as compared to Pancreaze®, a pig-derived PERT.

Age: 7 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: No FEV1 Limit

Number of Visits: 17

Length of Participation: 30 weeks

ClinicalTrial.gov link: https://www.clinicaltrials.gov/ct2/show/results/NCT03051490

Vitamin D for enhancing the immune system in people with CF

Status: Completed

Description: This study evaluated the effect of a single high-dose of vitamin D3 given at the start of a pulmonary exacerbation followed by vitamin D3 maintenance treatment in adults with CF.

Age: 16 Years and Older

Mutation: No Mutation Requirement

Fev1% Predicted: 20% or greater

Number of Visits: 6

Length of Participation: 1 years

ClinicalTrial.gov link: https://clinicaltrials.gov/ct2/show/NCT01426256

June 28, 2019

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: Enrolling

Description: This study will look at the safety and tolerability of PTI-808, a modulator intended to help CFTR protein function closer to normal. PTI-808 will be tested in combination with two other modulators, PTI-801 and PTI-428.

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