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US Army
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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR ZENPEP

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Clinical Trials for Zenpep

Trial ID Title Status Sponsor Phase Summary
NCT00788593 A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) Completed Forest Laboratories Phase 3 The primary efficacy objective of this study is to evaluate the difference in coefficient of fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in participants with EPI associated with CP. This study is sponsored by Aptalis Pharma (formerly Eurand).
NCT01100606 A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age Completed Forest Laboratories Phase 4 A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma (formerly Eurand).
NCT01131507 PR-018: An Open-Label, Safety Extension of Study PR-011 Completed Forest Laboratories Phase 4 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 ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Zenpep

Condition Name

Condition Name for Zenpep
Intervention Trials
Cystic Fibrosis 3
Exocrine Pancreatic Insufficiency 3
Chronic Pancreatitis 1
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Condition MeSH

Condition MeSH for Zenpep
Intervention Trials
Exocrine Pancreatic Insufficiency 4
Fibrosis 4
Cystic Fibrosis 4
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Clinical Trial Locations for Zenpep

Trials by Country

Trials by Country for Zenpep
Location Trials
United States 19
Italy 5
Ukraine 4
Belgium 1
Germany 1
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Trials by US State

Trials by US State for Zenpep
Location Trials
Florida 3
Texas 2
Pennsylvania 2
Ohio 2
Nevada 2
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Clinical Trial Progress for Zenpep

Clinical Trial Phase

Clinical Trial Phase for Zenpep
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Zenpep
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 1
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Clinical Trial Sponsors for Zenpep

Sponsor Name

Sponsor Name for Zenpep
Sponsor Trials
Forest Laboratories 4
Dana-Farber Cancer Institute 1
Allergan 1
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Sponsor Type

Sponsor Type for Zenpep
Sponsor Trials
Industry 5
Other 4
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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Chinese Patent Office
AstraZeneca
US Army
Accenture
Moodys
Fish and Richardson
Deloitte

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