PR-018: An Open-Label, Safety Extension of Study PR-011
A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)
1 other identifier
interventional
15
1 country
6
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2010
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
March 7, 2014
CompletedMarch 21, 2017
February 1, 2017
1.4 years
May 25, 2010
January 27, 2014
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE's relationship to study drug (unrelated, possible and probable) and on the basis of severity (mild \[minimal/no treatment and did not interfere with daily activities\], moderate \[resulted in a low level of inconvenience or concern with the therapeutic measures and may have caused some interference with functioning\] and severe \[interrupted participant's usual daily activity, may have required systemic drug therapy or other treatment and were usually incapacitating\]) with a frequency threshold of above 5% were reported.
Up to Month 12 or early termination
Secondary Outcomes (1)
Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
Baseline, Month 3, 6, 9 and 12
Study Arms (1)
EUR-1008 (APT-1008)
EXPERIMENTALInterventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Nemours Children's Clinic
Jacksonville, Florida, 32250, United States
Children's Lung Specialists Ltd.
Las Vegas, Nevada, 89107, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Cystic Fibrosis Care Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Winkler, MD, VP, Clinical Development and Operations
- Organization
- Aptalis Pharma US, Inc.
Study Officials
- STUDY DIRECTOR
Aptalis Medical Information
Forest Laboratories
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 27, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 21, 2017
Results First Posted
March 7, 2014
Record last verified: 2017-02