SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
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ClinicalTrials.gov Identifier: NCT02279498 |
Recruitment Status :
Completed
First Posted : October 31, 2014
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
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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 and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Exocrine Pancreatic Insufficiency Cystic Fibrosis | Drug: Liprotamase Drug: porcine (pig) PERT | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 128 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Randomized, Open-Label, Assessor-Blind, Noninferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency |
Actual Study Start Date : | June 2015 |
Actual Primary Completion Date : | October 2016 |
Actual Study Completion Date : | January 20, 2017 |

Arm | Intervention/treatment |
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Experimental: Liprotamase
Individually-optimized dose to be administered orally
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Drug: Liprotamase
oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement |
Active Comparator: porcine (pig) PERT
Individually-optimized dose to be administered orally
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Drug: porcine (pig) PERT
oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source |
- Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline [ Time Frame: Baseline, 7 weeks ]The primary endpoint evaluates the difference between treatment arms in change from baseline in coefficient of fat absorption (CFA). As such, descriptive statistics for individual treatment arms are not provided in this measure, but are reported in the secondary endpoints
- Coefficient of Fat Absorption (CFA) [ Time Frame: Baseline, 7 weeks ]Change from baseline in coefficient of fat absorption
- Coefficient of Nitrogen Absorption (CNA) [ Time Frame: Baseline, 7 weeks ]Change from baseline in coefficient of nitrogen absorption

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Ages Eligible for Study: | 7 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279498

Study Director: | Monica Gangal | Anthera Pharmaceuticals |
Responsible Party: | Anthera Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02279498 |
Other Study ID Numbers: |
AN-EPI3331 |
First Posted: | October 31, 2014 Key Record Dates |
Results First Posted: | August 14, 2018 |
Last Update Posted: | August 14, 2018 |
Last Verified: | July 2018 |
Cystic Fibrosis Exocrine Pancreatic Insufficiency Fibrosis Pathologic Processes Pancreatic Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |