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SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02279498
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Brief Summary:

Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.


Condition or disease Intervention/treatment Phase
Exocrine Pancreatic Insufficiency Cystic Fibrosis Drug: Liprotamase Drug: porcine (pig) PERT Phase 3

Detailed Description:
Porcine derived enzymes are used for pancreatic enzyme replacement therapy in patients with cystic fibrosis (CF). Liprotamase is a biotechnology-derived enzyme replacement without enteric coating. This is an open-label, assessor blind, parallel group, multicenter, international trial to evaluate the noninferiority of liprotamase and pancrelipase in CF patients aged ≥7 years with pancreatic insufficiency. Subjects were randomized to liprotamase or pancrelipase, dose-matched to pre-study lipase doses. The lower bound of the 95% confidence interval (CI) for noninferiority was -15% for treatment difference in change from baseline coefficient of fat absorption (CFA).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label, Assessor-Blind, Noninferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Actual Study Start Date : June 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : January 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Liprotamase
Individually-optimized dose to be administered orally
Drug: Liprotamase
oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement

Active Comparator: porcine (pig) PERT
Individually-optimized dose to be administered orally
Drug: porcine (pig) PERT
oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source




Primary Outcome Measures :
  1. Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline [ Time Frame: Baseline, 7 weeks ]
    The primary endpoint evaluates the difference between treatment arms in change from baseline in coefficient of fat absorption (CFA). As such, descriptive statistics for individual treatment arms are not provided in this measure, but are reported in the secondary endpoints


Secondary Outcome Measures :
  1. Coefficient of Fat Absorption (CFA) [ Time Frame: Baseline, 7 weeks ]
    Change from baseline in coefficient of fat absorption

  2. Coefficient of Nitrogen Absorption (CNA) [ Time Frame: Baseline, 7 weeks ]
    Change from baseline in coefficient of nitrogen absorption



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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:

  • Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride
  • Fecal elastase <100 mcg/g stool
  • Minimum Coefficient of Fat (CFA) at screening while on stable PERT therapy
  • Good nutritional status

Exclusion Criteria:

  • History or diagnosis of fibrosing colonopathy
  • Distal intestinal obstruction syndrome in 6 months prior to screening
  • Receiving enteral tube feedings
  • Chronic diarrheal illness unrelated to pancreatic insufficiency
  • Liver abnormalities, or liver or lung transplant, or significant bowel resection
  • Forced expiratory volume in 1 second (FEV1) <30%

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): NCT02279498


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Locations
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United States, California
Investigator Site 123
Long Beach, California, United States, 90806
Investigator Site 107
Los Angeles, California, United States, 90033
United States, Colorado
Investigator Site 114
Aurora, Colorado, United States, 80045
United States, Florida
Investigator Site 120
Gainesville, Florida, United States, 32610
Investigator Site 102
Jacksonville, Florida, United States, 32207
Investigator Site 130
Miami, Florida, United States, 33136
Investigator Site 117
Orlando, Florida, United States, 32803
United States, Georgia
Investigator Site 110
Atlanta, Georgia, United States, 30342
United States, Illinois
Investigator Site 127
Chicago, Illinois, United States, 60611
Investigator Site 109
Glenview, Illinois, United States, 60025
United States, Indiana
Investigator Site 104
Indianapolis, Indiana, United States, 46202
United States, Kansas
Investigator Site 105
Wichita, Kansas, United States, 67214
United States, Kentucky
Investigator Site 128
Lexington, Kentucky, United States, 40506
Investigator Site 122
Louisville, Kentucky, United States, 40202
United States, Maine
Investigator Site 132
Portland, Maine, United States, 04102
United States, Michigan
Investigator Site 124
Ann Arbor, Michigan, United States, 48109-5212
Investigator Site 126
East Lansing, Michigan, United States, 48823
United States, Mississippi
Investigator Site 134
Jackson, Mississippi, United States, 39216
United States, Nevada
Investigator Site 135
Las Vegas, Nevada, United States, 89107
United States, Ohio
Investigator Site 103
Cleveland, Ohio, United States, 44106
Investigator Site 113
Toledo, Ohio, United States, 43606
United States, Oklahoma
Investigator Site 101
Oklahoma City, Oklahoma, United States, 73104
Investigator Site 136
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Investigator Site 119
Portland, Oregon, United States, 97239
United States, Pennsylvania
Investigator Site 106
Hershey, Pennsylvania, United States, 17033
Investigator Site 115
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Investigator Site 111
Dallas, Texas, United States, 75390
Investigator Site 125
Fort Worth, Texas, United States, 76104
Investigator Site 116
Houston, Texas, United States, 77030
United States, Vermont
Investigator Site 121
Burlington, Vermont, United States, 05405
United States, Virginia
Investigator Site 112
Richmond, Virginia, United States, 23219
United States, West Virginia
Investigator Site 129
Morgantown, West Virginia, United States, 26506
Canada, Alberta
Investigator Site 133
Edmonton, Alberta, Canada, T6G IC9
Czechia
Investigator Site 501
Brno, Czechia, 62500
Investigator Site 502
Plzen, Czechia, 305 99
Hungary
Investigator Site 305
Szeged, Csongrad County, Hungary, 6720
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 208
Bialystok, Poland, 15-044
Investigator Site 203
Karpacz, Poland, 58-540
Investigator Site 206
Lodz, Poland, 90-329
Investigator Site 201
Lublin, Poland, 20-093
Investigator Site 205
Lublin, Poland, 20-362
Investigator Site 202
Rabka Zdroj, Poland, 34-700
Investigator Site 209
Rzeszow, Poland, 35-312
Investigator Site 204
Sopot, Poland, 81-713
Investigator Site 207
Warszawa, Poland, 01-195
Spain
Investigator Site 403
Madrid, Spain, 28006
Investigator Site 401
Madrid, Spain, 28046
Investigator Site 402
Malaga, Spain, 29009
Investigator Site 404
Valencia, Spain, 46026
Sponsors and Collaborators
Anthera Pharmaceuticals
Investigators
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Study Director: Monica Gangal Anthera Pharmaceuticals

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Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02279498     History of Changes
Other Study ID Numbers: AN-EPI3331
First Posted: October 31, 2014    Key Record Dates
Results First Posted: August 14, 2018
Last Update Posted: August 14, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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Fibrosis
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases