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

Forest Laboratories

Status and phase: Completed; Phase 4

Conditions: Cystic Fibrosis; Exocrine Pancreatic Insufficiency

Treatments: Drug: EUR-1008 (APT-1008)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01131507

PR-018

Details and patient eligibility

About

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).

Full description

This is a multi-center, open-label, safety extension of Aptalis (formerly Eurand) study PR-011 (NCT01100606) in pediatric participants with EPI due to CF. The study will be carried out in participants who completed the PR-011 study.

The study is comprised of 5 visits: an enrollment visit, treatment visit 1 (3 months), treatment visit 2 (6 months), treatment visit 3 (9 months) and treatment visit 4 (12 months). Once determined eligible for participation, participants will be enrolled into the study.

Enrollment: 15 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

EUR-1008 (APT-1008)

Experimental group

Treatment:

Drug: EUR-1008 (APT-1008)