Status:
COMPLETED
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Lead Sponsor:
Anthera Pharmaceuticals
Conditions:
Exocrine Pancreatic Insufficiency
Cystic Fibrosis
Eligibility:
All Genders
7+ years
Phase:
PHASE3
Brief Summary
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy a...
Detailed Description
Porcine derived enzymes are used for pancreatic enzyme replacement therapy in patients with cystic fibrosis (CF). Liprotamase is a biotechnology-derived enzyme replacement without enteric coating. Thi...
Eligibility Criteria
Inclusion
- Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride
- Fecal elastase \<100 mcg/g stool
- Minimum Coefficient of Fat (CFA) at screening while on stable PERT therapy
- Good nutritional status
Exclusion
- History or diagnosis of fibrosing colonopathy
- Distal intestinal obstruction syndrome in 6 months prior to screening
- Receiving enteral tube feedings
- Chronic diarrheal illness unrelated to pancreatic insufficiency
- Liver abnormalities, or liver or lung transplant, or significant bowel resection
- Forced expiratory volume in 1 second (FEV1) \<30%
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2017
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT02279498
Start Date
June 1 2015
End Date
January 20 2017
Last Update
August 14 2018
Active Locations (54)
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1
Investigator Site 123
Long Beach, California, United States, 90806
2
Investigator Site 107
Los Angeles, California, United States, 90033
3
Investigator Site 114
Aurora, Colorado, United States, 80045
4
Investigator Site 120
Gainesville, Florida, United States, 32610