drugset / Trial / NCT01131507
PR-018: An Open-Label, Safety Extension of Study PR-011
NaSingle-groupOpen-labelTreatment
Summary
A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® \[pancrelipase\] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
Timeline
- Start
- 2010-07
- Primary completion
- 2011-12
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pancrelipase | Protein / enzyme biologic | 3000 iu | Oral |