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EASY: Extended Access to Sollpura Over Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02823964
Recruitment Status : Completed
First Posted : July 6, 2016
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency Cystic Fibrosis Drug: Liprotamase Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Liprotamase
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
 Drug: Liprotamase
Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
Other Name: Sollpura


Outcome Measures
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Primary Outcome Measures :
  1. Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities [ Time Frame: 12 months ]
    Descriptive analysis


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823964


Locations
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United States, Colorado
Investigator Site 114
Aurora, Colorado, United States, 80045
United States, Mississippi
Investigator Site 134
Jackson, Mississippi, United States, 39216
United States, Vermont
Investigator Site 121
Burlington, Vermont, United States, 05401
Czechia
Investigator Site 501
Brno, Czechia, 625 00
Hungary
Investigator Site 303
Debrecen, Hajdu-Bihar, Hungary, 4031
Investigator Site 302
Torokbalint, Pest County, Hungary, 2045
Investigator Site 304
Mosdos, Somogy County, Hungary, 7257
Investigator Site 301
Ajka, Veszprem County, Hungary, 8400
Israel
Investigator Site 601
Jerusalem, Israel, 9124001
Poland
Investigator Site 203
Karpacz, Poland, 58-540
Investigator Site 206
Lodz, Poland, 90-329
Investigator Site 205
Lublin, Poland, 20-362
Investigator Site 202
Rabka-Zdroj, Poland, 34-700
Investigator Site 209
Rzeszow, Poland, 35-612
Spain
Investigator Site 401
Madrid, Spain, 28046
Sponsors and Collaborators
Anthera Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Anthera Pharmaceuticals:
Study Protocol and Statistical Analysis Plan  [PDF] October 31, 2017

More Information
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Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02823964    
Other Study ID Numbers: AN-EPI3334
First Posted: July 6, 2016    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Anthera Pharmaceuticals:
exocrine pancreatic insufficiency
cystic fibrosis
pancreatic enzyme replacement therapy
Additional relevant MeSH terms:
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Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Fibrosis
Pathologic Processes
Pancreatic Diseases
 Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases