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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. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age |
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| Part B | Experimental | Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liprotamase Powder for Oral Solution | Drug | Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Number of subjects reporting 1 or more adverse events | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 139 | Little Rock | Arkansas | 72202 | United States | ||
| Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A | Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy |
| FG001 | Part B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Orange |
| California |
| 92868 |
| United States |
| Investigator Site 114 | Aurora | Colorado | 80045 | United States |
| Investigator Site 117 | Altamonte Springs | Florida | 32701 | United States |
| Investigator Site 138 | Hollywood | Florida | 33021 | United States |
| Investigator Site 130 | Miami | Florida | 33136 | United States |
| Investigator Site 110 | Atlanta | Georgia | 30342 | United States |
| Investigator Site 109 | Glenview | Illinois | 60025 | United States |
| Investigator Site 105 | Wichita | Kansas | 67214 | 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 135 | Las Vegas | Nevada | 89107 | United States |
| Investigator Site 118 | Durham | North Carolina | 27710 | United States |
| Investigator Site 101 | Oklahoma City | Oklahoma | 73104 | United States |
| Investigator Site 136 | Oklahoma City | Oklahoma | 73112 | United States |
| Investigator Site 106 | Hershey | Pennsylvania | 17033 | United States |
| Investigator Site 111 | Dallas | Texas | 75390-9063 | United States |
| Investigator Site 116 | Houston | Texas | 77030 | United States |
| Investigator Site 112 | Richmond | Virginia | 23298 | United States |
| Investigator Site 129 | Morgantown | West Virginia | 26506 | United States |
Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years
Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A | Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy |
| BG001 | Part B | Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety | Number of subjects reporting 1 or more adverse events | Posted | Count of Participants | Participants | 1 week |
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1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A | Liprotamase Powder for Oral Solution in Subjects aged ≥7 years of age Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy | 0 | 15 | 1 | 15 | 3 | 15 |
| EG001 | Part B | Liprotamase Powder for Oral Solution in Subjects aged 28 days to <7 years Liprotamase Powder for Oral Solution: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroduodenitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infective exacerbation of cystic fibrosis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Monica Gangal | Anthera Pharmaceuticals | 510-856-5600 | info@anthera.com |
| ID | Term |
|---|---|
| D010188 | Exocrine Pancreatic Insufficiency |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| C515846 | liprotamase lipase |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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