Burlulipase in People with CF and Pancreatic Insufficiency
Study Type:
Interventional
Intervention Category:
Nutritional-GI Therapies
Study Sponsor:
Nordmark Pharma
Study Phase:
2
Recruitment Status:
Not Yet Recruiting
Study Drug(s):
Not Applicable
Number of Participants Being Recruited:
25
Single / Multi-Center:
Multi-Center
STUDY BACKGROUND INFORMATION:
The purpose of this trial is to look at the effectiveness of burlulipase compared to placebo in people with CF who are ages 12 years and older and are pancreatic insufficient. Specimens of blood, urine, and stool will be taken in this trial. The trial will take up to 7 weeks.
ELIGIBILITY
Age:
>= 12 Years
FEV1:
Not Applicable
P. aeruginosa status:
Not applicable
B. cepacia status:
Not applicable
Other Primary Eligibility Requirements:
Potentially eligible subjects must be receiving PERT with a commercially available pancreatic enzyme.
Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific
trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
