Back to resultsEASY: Extended Access to Sollpura Over Years
Primary Purpose
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Liprotamase
Sponsored by
About this trial
This is an interventional treatment trial for Exocrine Pancreatic Insufficiency focused on measuring exocrine pancreatic insufficiency, cystic fibrosis, pancreatic enzyme replacement therapy
Eligibility Criteria
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.
Sites / Locations
- Investigator Site 114
- Investigator Site 134
- Investigator Site 121
- Investigator Site 501
- Investigator Site 303
- Investigator Site 302
- Investigator Site 304
- Investigator Site 301
- Investigator Site 601
- Investigator Site 203
- Investigator Site 206
- Investigator Site 205
- Investigator Site 202
- Investigator Site 209
- Investigator Site 401
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Liprotamase
Arm Description
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Outcomes
Primary Outcome Measures
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
Descriptive analysis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02823964
Brief Title
EASY: Extended Access to Sollpura Over Years
Official Title
An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anthera Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Keywords
exocrine pancreatic insufficiency, cystic fibrosis, pancreatic enzyme replacement therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liprotamase
Arm Type
Experimental
Arm Description
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Intervention Type
Drug
Intervention Name(s)
Liprotamase
Other Intervention Name(s)
Sollpura
Intervention Description
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Primary Outcome Measure Information:
Title
Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities
Description
Descriptive analysis
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigator Site 114
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Investigator Site 134
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Investigator Site 121
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Investigator Site 501
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Investigator Site 303
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Investigator Site 302
City
Torokbalint
State/Province
Pest County
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Investigator Site 304
City
Mosdos
State/Province
Somogy County
ZIP/Postal Code
7257
Country
Hungary
Facility Name
Investigator Site 301
City
Ajka
State/Province
Veszprem County
ZIP/Postal Code
8400
Country
Hungary
Facility Name
Investigator Site 601
City
Jerusalem
ZIP/Postal Code
9124001
Country
Israel
Facility Name
Investigator Site 203
City
Karpacz
ZIP/Postal Code
58-540
Country
Poland
Facility Name
Investigator Site 206
City
Lodz
ZIP/Postal Code
90-329
Country
Poland
Facility Name
Investigator Site 205
City
Lublin
ZIP/Postal Code
20-362
Country
Poland
Facility Name
Investigator Site 202
City
Rabka-Zdroj
ZIP/Postal Code
34-700
Country
Poland
Facility Name
Investigator Site 209
City
Rzeszow
ZIP/Postal Code
35-612
Country
Poland
Facility Name
Investigator Site 401
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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EASY: Extended Access to Sollpura Over Years
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