EASY: Extended Access to Sollpura Over Years

Anthera Pharmaceuticals25 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 evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Exocrine Pancreatic Insufficiency Cystic Fibrosis

Interventions

LiprotamaseDRUG

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

Eligibility

Sex: ALLMin age: 7 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female subjects with cystic fibrosis-related exocrine pancreatic insufficiency who received liprotamase and completed Study AN-EPI3331 (SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis) Exclusion Criteria: * Any medical, psychological, or social condition that may put the subject at increased risk by participating in this study. * Females who are nursing, pregnant, intending to become pregnant, or intending to nurse during the time of the study.

Locations (15)

Investigator Site 114

Aurora, Colorado, United States

Investigator Site 134

Jackson, Mississippi, United States

Investigator Site 121

Burlington, Vermont, United States

Outcomes

Primary Outcomes

Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities

Descriptive analysis

Time frame: 12 months

Data from ClinicalTrials.gov

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