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Study Name: Efficacy and Safety of Pancrelipase Delayed Release Capsules in Young Children with CF
Study Type: Interventional
Intervention Category: Nutritional-GI Therapies
Study Sponsor: AbbVie
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Creon
Number of Participants Being Recruited: 18
Single / Multi-Center: Multi-Center
Pancreatic enzyme replacement therapy is important for normal growth and development in children with CF who have pancreatic insufficiency. The use and safety of current enzyme replacement therapy has been shown in other clinical trials in CF patients with pancreatic insufficiency. This study will look at the use and safety of a new formulation of an enzyme replacement therapy and its effect on fat absorption in CF patients with pancreatic insufficiency.
Age: 1 Months - 6 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on If a specific trial listing for this trial is available, a link to the specific listing will be present in the "More Information" section below.
Sponsor Contact Information:
Trial Specific Link on
Clinical Research Terms Glossary: Click here
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.
  • Saint Luke's Cystic Fibrosis Center of Idaho (Pediatric), Boise, ID, 83712
    Contact Information:
        Durham, Dixie
        Phone: (208) 381-7334
  • University of Louisville (Pediatric), Louisville, KY, 40202
    Contact Information:
        Tomazin, Janet
        Phone: (502) 852-3772
  • Children's Hospital of Michigan (Pediatric), Detroit, MI, 48201
    Contact Information:
        Van Wagnen, Catherine
        Phone: (313) 745-4737
  • Children's Hospitals and Clinics (Pediatric), Minneapolis, MN, 55404
    Contact Information:
        Johnson, Mahrya
        Phone: (612) 813-6384
  • Monmouth Medical Center (Pediatric), Long Branch, NJ, 07740
    Contact Information:
        Marra, Bridget
        Phone: (732) 222-4474
  • Toldeo Children's Hospital (Pediatric), Toledo, OH, 43606
    Contact Information:
        Houser, Kelly
        Phone: (419) 291-4630
  • Oklahoma Cystic Fibrosis Center (Pediatric), Oklahoma City, OK, 73104
    Contact Information:
        Fox, Jodie
        Phone: (405) 271-6216
  • Hershey Medical Center Pennsylvania State University (Pediatric), Hershey, PA, 17033
    Contact Information:
        Kitch, Diane
        Phone: (717) 531-5646
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