15
Participants
Start Date
July 31, 2010
Primary Completion Date
December 31, 2011
Study Completion Date
December 31, 2011
EUR-1008 (APT-1008)
EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose will be adjusted based on participants' age and body weight. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment will be up to 12 months.
Penn State Milton S. Hershey Medical Center, Hershey
Nemours Children's Clinic, Jacksonville
Akron Children's Hospital, Akron
Cincinnati Children's Hospital Medical Center, Cincinnati
Cystic Fibrosis Care Center, Houston
Children's Lung Specialists Ltd., Las Vegas
Lead Sponsor
Forest Laboratories
INDUSTRY