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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 evaluate the safety of long-term use of liprotamase in the management of cystic fibrosis-related exocrine pancreatic insufficiency
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liprotamase | Experimental | Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liprotamase | Drug | Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities | Descriptive analysis | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 114 | Aurora | Colorado | 80045 | United States | ||
| Investigator Site 134 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liprotamase | Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liprotamase | Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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, as Measured by Number of Participants With Adverse Events Including Clinical or Laboratory Abnormalities | Descriptive analysis | Posted | Count of Participants | Participants | 12 months |
|
|
1 year
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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 | Liprotamase | Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement Liprotamase: Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Ramza | Anthera Pharmaceuticals | 510-856-5600 | info@anthera.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2017 | Apr 19, 2018 | Prot_SAP_000.pdf |
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| 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 |
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| ID | Term |
|---|---|
| C515846 | liprotamase lipase |
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| Jackson |
| Mississippi |
| 39216 |
| United States |
| Investigator Site 121 | Burlington | Vermont | 05401 | United States |
| Investigator Site 501 | Brno | 625 00 | Czechia |
| 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 203 | Karpacz | 58-540 | Poland |
| Investigator Site 206 | Lodz | 90-329 | Poland |
| Investigator Site 205 | Lublin | 20-362 | Poland |
| Investigator Site 202 | Rabka-Zdrój | 34-700 | Poland |
| Investigator Site 209 | Rzeszów | 35-612 | Poland |
| Investigator Site 401 | Madrid | 28046 | Spain |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 0 |
| 25 |
| 3 |
| 25 |
| 9 |
| 25 |
| Scalded Skin | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
|
| Hemoptoe | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Infective pulmonary exacerbation of CF | Infections and infestations | Systematic Assessment |
|
| Viral infection | Infections and infestations | Systematic Assessment |
|
| Scalded skin | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | Systematic Assessment |
|
| Investigations | Investigations | Systematic Assessment |
|
| Minocycline allergy | Immune system disorders | Systematic Assessment |
|
| Abdominal pain | General disorders | Systematic Assessment |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |