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:
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.
The sites listed below are currently recruiting subjects. Please note that this list generally lists either the pediatric or adult program but not both even though both programs may be recruiting subjects. Also, this list does not include sites that may be participating in the study but are not yet open for recruitment. If you are interested in this study please contact your center for more information.
