EASY: Extended Access to Sollpura Over Years

Cystic Fibrosis Clinical Trial

Official title:

An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823964
• Other study ID #: AN-EPI3334
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: April 2018
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Exocrine Pancreatic Insufficiency
• Fibrosis

Intervention

Drug:
• Liprotamase
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement

Locations

Country	Name	City	State
Czechia	Investigator Site 501	Brno
Hungary	Investigator Site 301	Ajka	Veszprem County
Hungary	Investigator Site 303	Debrecen	Hajdu-Bihar
Hungary	Investigator Site 304	Mosdos	Somogy County
Hungary	Investigator Site 302	Torokbalint	Pest County
Israel	Investigator Site 601	Jerusalem
Poland	Investigator Site 203	Karpacz
Poland	Investigator Site 206	Lodz
Poland	Investigator Site 205	Lublin
Poland	Investigator Site 202	Rabka-Zdroj
Poland	Investigator Site 209	Rzeszow
Spain	Investigator Site 401	Madrid
United States	Investigator Site 114	Aurora	Colorado
United States	Investigator Site 121	Burlington	Vermont
United States	Investigator Site 134	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czechia,  Hungary,  Israel,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities	Descriptive analysis	12 months