SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis (SIMPLICITY)
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ClinicalTrials.gov Identifier: NCT02734810 |
Recruitment Status :
Completed
First Posted : April 12, 2016
Results First Posted : May 11, 2018
Last Update Posted : May 11, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Exocrine Pancreatic Insufficiency Cystic Fibrosis | Drug: Liprotamase Powder for Oral Solution | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency |
Actual Study Start Date : | June 2016 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | March 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Part A
Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age
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Drug: Liprotamase Powder for Oral Solution
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
Other Name: Liprotamase |
Experimental: Part B
Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years
|
Drug: Liprotamase Powder for Oral Solution
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
Other Name: Liprotamase |
- Safety [ Time Frame: 1 week ]Number of subjects reporting 1 or more adverse events

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- For Part A: males or females ≥7 years of age
- For Part B: males or females 28 days to <7 years
- Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride
- Low fecal elastase
- Fair-to-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

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): NCT02734810

Responsible Party: | Anthera Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02734810 |
Other Study ID Numbers: |
AN-EPI3332 |
First Posted: | April 12, 2016 Key Record Dates |
Results First Posted: | May 11, 2018 |
Last Update Posted: | May 11, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Exocrine Pancreatic Insufficiency Cystic Fibrosis Liprotamase Pancreatic Enzyme Replacement Therapy (PERT) |
Cystic Fibrosis Exocrine Pancreatic Insufficiency Fibrosis Pathologic Processes Pancreatic Diseases |
Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |