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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Cystic Fibrosis Exocrine Pancreatic Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EUR-1008 (APT-1008)

Group Type EXPERIMENTAL

EUR-1008 (APT-1008)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Zenpep® (pancrelipase) 3,000 lipase units delayed release capsules

Eligibility Criteria

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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

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No