SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

Phase 3

Completed

• Conditions: Exocrine Pancreatic Insufficiency; Cystic Fibrosis
• Interventions: Drug: Liprotamase Powder for Oral Solution

• Registration Number: NCT02734810
• Lead Sponsor: Anthera Pharmaceuticals

Brief Summary

Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-06
• Study First Submitted QC: 2016-04-11
• Study First Posted: 2016-04-12
• Study Start: 2016-06
• Primary Completion: 2016-12
• Study Completion: 2017-03
• Status Verified: 2018-04
• Results First Submitted: 2018-04-10
• Results First Submitted QC: 2018-04-10
• Last Update Submitted: 2018-04-10
• Results First Posted: 2018-05-11
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part A	Liprotamase Powder for Oral Solution	Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age
Part B	Liprotamase Powder for Oral Solution	Liprotamase Powder for Oral Solution in Subjects aged 28 days to \<7 years

Primary Outcome Measures

Name	Time	Method
Safety	1 week	Number of subjects reporting 1 or more adverse events

Trial Locations

Locations (21)

Investigator Site 114; 🇺🇸 Aurora, Colorado, United States

Investigator Site 130; 🇺🇸 Miami, Florida, United States

Investigator Site 122; 🇺🇸 Louisville, Kentucky, United States

Investigator Site 110; 🇺🇸 Atlanta, Georgia, United States

Investigator Site 109; 🇺🇸 Glenview, Illinois, United States

Investigator Site 111; 🇺🇸 Dallas, Texas, United States

Investigator Site 124; 🇺🇸 Ann Arbor, Michigan, United States

Investigator Site 135; 🇺🇸 Las Vegas, Nevada, United States

Investigator Site 118; 🇺🇸 Durham, North Carolina, United States

Investigator Site 101; 🇺🇸 Oklahoma City, Oklahoma, United States

Investigator Site 136; 🇺🇸 Oklahoma City, Oklahoma, United States

Investigator Site 116; 🇺🇸 Houston, Texas, United States

Investigator Site 139; 🇺🇸 Little Rock, Arkansas, United States

Investigator Site; 🇺🇸 Orange, California, United States

Investigator Site 117; 🇺🇸 Altamonte Springs, Florida, United States

Investigator Site 138; 🇺🇸 Hollywood, Florida, United States

Investigator Site 105; 🇺🇸 Wichita, Kansas, United States

Investigator Site 132; 🇺🇸 Portland, Maine, United States

Investigator Site 106; 🇺🇸 Hershey, Pennsylvania, United States

Investigator Site 129; 🇺🇸 Morgantown, West Virginia, United States

Investigator Site 112; 🇺🇸 Richmond, Virginia, United States