SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

Anthera Pharmaceuticals15 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Exocrine Pancreatic Insufficiency Cystic Fibrosis

Interventions

Liprotamase Powder for Oral SolutionDRUG

Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy

Eligibility

Sex: ALLMin age: 28 Days

Medical Language ↔ Plain English

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

Locations (21)

Investigator Site 139

Little Rock, Arkansas, United States

Investigator Site

Outcomes

Primary Outcomes

Safety

Number of subjects reporting 1 or more adverse events

Time frame: 1 week

Data from ClinicalTrials.gov

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