PR-018: An Open-Label, Safety Extension of Study PR-011

PHASE4CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Cystic FibrosisExocrine Pancreatic Insufficiency
Interventions
DRUG

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.

Trial Locations (6)

17033

Penn State Milton S. Hershey Medical Center, Hershey

32250

Nemours Children's Clinic, Jacksonville

44308

Akron Children's Hospital, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

77030

Cystic Fibrosis Care Center, Houston

89107

Children's Lung Specialists Ltd., Las Vegas

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY