EASY: Extended Access to Sollpura Over Years

Phase 4

Completed

• Conditions: Exocrine Pancreatic Insufficiency; Cystic Fibrosis
• Interventions: Drug: Liprotamase

• Registration Number: NCT02823964
• 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.

Detailed 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

Study Timeline

• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Study Start: 2016-09
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2018-04
• Results First Submitted: 2018-04-19
• Results First Submitted QC: 2018-04-19
• Last Update Submitted: 2018-04-19
• Results First Posted: 2018-05-17
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liprotamase	Liprotamase	Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement

Primary Outcome Measures

Name	Time	Method
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities	12 months	Descriptive analysis

Trial Locations

Locations (15)

Investigator Site 134; 🇺🇸 Jackson, Mississippi, United States

Investigator Site 121; 🇺🇸 Burlington, Vermont, United States

Investigator Site 304; 🇭🇺 Mosdos, Somogy County, Hungary

Investigator Site 601; 🇮🇱 Jerusalem, Israel

Investigator Site 303; 🇭🇺 Debrecen, Hajdu-Bihar, Hungary

Investigator Site 501; 🇨🇿 Brno, Czechia

Investigator Site 401; 🇪🇸 Madrid, Spain

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

Investigator Site 302; 🇭🇺 Torokbalint, Pest County, Hungary

Investigator Site 301; 🇭🇺 Ajka, Veszprem County, Hungary

Investigator Site 203; 🇵🇱 Karpacz, Poland

Investigator Site 205; 🇵🇱 Lublin, Poland

Investigator Site 202; 🇵🇱 Rabka-Zdroj, Poland

Investigator Site 209; 🇵🇱 Rzeszow, Poland

Investigator Site 206; 🇵🇱 Lodz, Poland