SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
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
1 other identifier
interventional
128
7 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2015
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2017
CompletedResults Posted
Study results publicly available
August 14, 2018
CompletedAugust 14, 2018
July 1, 2018
1.3 years
October 28, 2014
April 10, 2018
July 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment Difference in Coefficient of Fat Absorption (CFA) Change From Baseline
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
Baseline, 7 weeks
Secondary Outcomes (2)
Coefficient of Fat Absorption (CFA)
Baseline, 7 weeks
Coefficient of Nitrogen Absorption (CNA)
Baseline, 7 weeks
Study Arms (2)
Liprotamase
EXPERIMENTALIndividually-optimized dose to be administered orally
porcine (pig) PERT
ACTIVE COMPARATORIndividually-optimized dose to be administered orally
Interventions
oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Investigator Site 123
Long Beach, California, 90806, United States
Investigator Site 107
Los Angeles, California, 90033, United States
Investigator Site 114
Aurora, Colorado, 80045, United States
Investigator Site 120
Gainesville, Florida, 32610, United States
Investigator Site 102
Jacksonville, Florida, 32207, United States
Investigator Site 130
Miami, Florida, 33136, United States
Investigator Site 117
Orlando, Florida, 32803, United States
Investigator Site 110
Atlanta, Georgia, 30342, United States
Investigator Site 127
Chicago, Illinois, 60611, United States
Investigator Site 109
Glenview, Illinois, 60025, United States
Investigator Site 104
Indianapolis, Indiana, 46202, United States
Investigator Site 105
Wichita, Kansas, 67214, United States
Investigator Site 128
Lexington, Kentucky, 40506, United States
Investigator Site 122
Louisville, Kentucky, 40202, United States
Investigator Site 132
Portland, Maine, 04102, United States
Investigator Site 124
Ann Arbor, Michigan, 48109-5212, United States
Investigator Site 126
East Lansing, Michigan, 48823, United States
Investigator Site 134
Jackson, Mississippi, 39216, United States
Investigator Site 135
Las Vegas, Nevada, 89107, United States
Investigator Site 103
Cleveland, Ohio, 44106, United States
Investigator Site 113
Toledo, Ohio, 43606, United States
Investigator Site 101
Oklahoma City, Oklahoma, 73104, United States
Investigator Site 136
Oklahoma City, Oklahoma, 73112, United States
Investigator Site 119
Portland, Oregon, 97239, United States
Investigator Site 106
Hershey, Pennsylvania, 17033, United States
Investigator Site 115
Pittsburgh, Pennsylvania, 15224, United States
Investigator Site 111
Dallas, Texas, 75390, United States
Investigator Site 125
Fort Worth, Texas, 76104, United States
Investigator Site 116
Houston, Texas, 77030, United States
Investigator Site 121
Burlington, Vermont, 05405, United States
Investigator Site 112
Richmond, Virginia, 23219, United States
Investigator Site 129
Morgantown, West Virginia, 26506, United States
Investigator Site 133
Edmonton, Alberta, T6G IC9, Canada
Investigator Site 501
Brno, 62500, Czechia
Investigator Site 502
Pilsen, 305 99, Czechia
Investigator Site 305
Szeged, Csongrád megye, 6720, Hungary
Investigator Site 303
Debrecen, Hajdú-Bihar, 4031, Hungary
Investigator Site 302
Törökbálint, Pest County, 2045, Hungary
Investigator Site 304
Mosdós, Somogy County, 7257, Hungary
Investigator Site 301
Ajka, Veszprém megye, 8400, Hungary
Investigator Site 601
Jerusalem, 9124001, Israel
Investigator Site 208
Bialystok, 15-044, Poland
Investigator Site 203
Karpacz, 58-540, Poland
Investigator Site 206
Lodz, 90-329, Poland
Investigator Site 201
Lublin, 20-093, Poland
Investigator Site 205
Lublin, 20-362, Poland
Investigator Site 202
Rabka-Zdrój, 34-700, Poland
Investigator Site 209
Rzeszów, 35-312, Poland
Investigator Site 204
Sopot, 81-713, Poland
Investigator Site 207
Warsaw, 01-195, Poland
Investigator Site 403
Madrid, 28006, Spain
Investigator Site 401
Madrid, 28046, Spain
Investigator Site 402
Málaga, 29009, Spain
Investigator Site 404
Valencia, 46026, Spain
Related Publications (1)
Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.
PMID: 32761612DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Monica Gangal
- Organization
- Anthera Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Monica Gangal
Anthera Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2014
First Posted
October 31, 2014
Study Start
June 1, 2015
Primary Completion
October 1, 2016
Study Completion
January 20, 2017
Last Updated
August 14, 2018
Results First Posted
August 14, 2018
Record last verified: 2018-07