EASY: Extended Access to Sollpura Over Years

Anthera Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Cystic Fibrosis; Exocrine Pancreatic Insufficiency

Treatments: Drug: Liprotamase

Study type: Interventional

Funder types: Industry

Identifiers

NCT02823964

AN-EPI3334

Details and patient eligibility

About

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.

Full description

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

Enrollment: 25 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Liprotamase

Experimental group

Description:

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

Treatment:

Drug: Liprotamase