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

Completed · Phase 4

Conditions studied: Cystic Fibrosis, Exocrine Pancreatic Insufficiency

In brief

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).

Key facts

Study ID

NCT01131507

Run by

Forest Laboratories

People needed

15

Starts

2010-07-01

Expected to finish

2011-12-01

Last updated by the study team

2017-03-21

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant's parent or guardian signed informed consent form (ICF)
• Participants who have completed study PR-011 (NCT01100606)

You may not qualify if…

• Participant having any condition that would, in the investigator's opinion, limit the participant's ability to complete the study or will result in excess risk to the participant that is above the standard of care

Where it is running

• Nemours Children's Clinic — Jacksonville, Florida, United States
• Children's Lung Specialists Ltd. — Las Vegas, Nevada, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Cystic Fibrosis Care Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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