Not provided
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Prematurely stopped in agreement with authorities (FDA)
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Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at least 90 days and up to 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoflipid | Experimental | Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3). |
|
| Intralipid, 20% | Active Comparator | Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoflipid | Drug | The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight of patients (patients < 36 months of age) | from day 1 monthly to day 365 |
| Body Height | Height oder length of body (patients <36 months of age) | from day 1 monthly to day 365 |
| Head Circumference | Circumference of head in patients > 36 months old | from day 1 monthly to day 365 |
| Fatty Acid Profile in Total Plasma | Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in total plasma | from day 1 monthly to day 365 |
| Fatty Acid Profile in Red Blood Cell Membranes | Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in red blood cell membranes | from day 1 monthly to day 365 |
| Triene/Tetraene Ratio | Triene/tetraene ratio (Holman Index) in total plasma to assess essential fatty acid deficiency (EFAD) | from day 1 weekly to day 365 |
| Number of Patients in Each Treatment Group With Direct Bilirubin Levels > 2 mg/dL | from day 1 monthly to day 365 | |
| Time Until Reaching Direct Bilirubin Levels > 2 mg/dL |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Rudolph, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Smoflipid | Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3). Smoflipid: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. |
| FG001 | Intralipid, 20% | Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid. Intralipid, 20%: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study was prematurely terminated
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Smoflipid | Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3). Smoflipid: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. |
| 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 | Body Weight | Body weight of patients (patients < 36 months of age) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
Adverse events were collected at each study visit until one day after the end of last study treatment (i.e., Study Day 365 in maximum).
There was only one patient treated in the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smoflipid | Smoflipid is a sterile, nonpyrogenic, white, homogenous lipid emulsion for intravenous infusion. The lipid content of Smoflipid is 0.20 g/mL, and comprises a mixture of soybean oil, medium chain triglycerides, olive oil, and fish oil. Smoflipid is indicated as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. The mean essential fatty acid content of Smoflipid is 35 mg/mL linoleic acid (omega-6) and 4.5 mg/mL α-linolenic acid (omega-3). Smoflipid: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BACTERAEMIA | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | Non-systematic Assessment |
The study was released from postmarketing requirement and the product received marketing authorization approval from the U.S. Food & Drug Administration. Therefore, the study was early terminated after treatment of a single patient.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Marc Lohse, PhD | Fresenius Kabi Germany | +49 6172 | 4911 | jean-marc.lohse@fresenius-kabi.com |
Not provided
| 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 | Feb 19, 2019 | Sep 28, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| D006963 | Hyperphagia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000709826 | SMOFlipid |
| C545823 | soybean oil, phospholipid emulsion |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Intralipid, 20% | Drug | The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. |
|
|
| from day 1 monthly to day 365 |
| Sterols in Plasma Including Phytosterols | from day 1 monthly to day 365 |
| Change From Baseline Triglycerides | from day 1 weekly to day 365 |
| Change From Baseline Urea Nitrogen | from day 1 weekly to day 365 |
| Change From Baseline Alanine Aminotransferase (ALT) | from day 1 weekly to day 365 |
| Change From Baseline Aspartate Aminotransferase (AST) | from day 1 weekly to day 365 |
| Change From Baseline Direct Bilirubin | from day 1 weekly to day 365 |
| Change From Baseline Total Bilirubin | from day 1 weekly to day 365 |
| Change From Baseline Gamma-glutamyl Transferase (GGT) | from day 1 weekly to day 365 |
| Change Form Baseline Alkaline Phosphatase (ALP) | from day 1 weekly to day 365 |
| Change From Baseline Creatinine | from day 1 weekly to day 365 |
| Change From Baseline Electrolytes (Na, K, Mg, Cl,Ca, Phosphate) | from day 1 weekly to day 365 |
| Change From Baseline Trace Elements (Ferritin, Zn, Se, Cu, Mn, Cr) | from day 1 weekly to day 365 |
| Change From Baseline Glucose | from day 1 weekly to day 365 |
| Change From Baseline Total Protein | from day 1 weekly to day 365 |
| Change From Baseline C-reactive Protein (CRP) | from day 1 weekly to day 365 |
| Change From Baseline White Blood Cell (WBC) Count | from day 1 weekly to day 365 |
| Change From Baseline Red Blood Cell (RBC) Count | from day 1 weekly to day 365 |
| Change From Baseline Platelet Count | from day 1 weekly to day 365 |
| Change From Baseline Hemoglobin | from day 1 weekly to day 365 |
| Change From Baseline Hematocrit | from day 1 weekly to day 365 |
| Change From Baseline International Normalized Ratio (INR) | from day 1 weekly to day 365 |
| Change From Baseline Sterols (Beta-sitosterol, Campesterol, Stigmasterol, Brassicasterol, Ergosterol, Cholesterol, Desmosterol, Lanosterol, Beta-sitostanol, Lathosterol, Squalene) | from day 1 monthly to day 365 |
| Vital Signs: Blood Pressure | Systolic and diastolic blood pressure | from day 1 monthly to day 365 |
| Vital Signs: Heart Rate | from day 1 monthly to day 365 |
| Vital Signs: Body Temperature | from day 1 monthly to day 365 |
| Adverse Events | from day 1 weekly to day 365 |
| Genetic Polymorphisms of Fatty Acid Desaturase Genes FADS1 and FADS2 | The relation between genetic polymorphisms in the fatty acid desaturase genes Fatty acid desaturase 1 (FADS1) and Fatty acid desaturase 2 (FADS2) and plasma concentrations of linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid, and Mead acid, as well as relation to and EFAD (triene/tetraene ratio) | once during treatment phase (day 1 to day 365) |
| BG001 | Intralipid, 20% | Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid. Intralipid, 20%: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body mass index | Mean | Full Range | kg/m² |
|
| OG001 | Intralipid, 20% | Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid. Intralipid, 20%: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. |
|
| Primary | Body Height | Height oder length of body (patients <36 months of age) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Head Circumference | Circumference of head in patients > 36 months old | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Fatty Acid Profile in Total Plasma | Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in total plasma | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Fatty Acid Profile in Red Blood Cell Membranes | Fatty acid profile including linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid and Mead acid, analyzed in red blood cell membranes | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Triene/Tetraene Ratio | Triene/tetraene ratio (Holman Index) in total plasma to assess essential fatty acid deficiency (EFAD) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Number of Patients in Each Treatment Group With Direct Bilirubin Levels > 2 mg/dL | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Time Until Reaching Direct Bilirubin Levels > 2 mg/dL | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Sterols in Plasma Including Phytosterols | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Change From Baseline Triglycerides | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Urea Nitrogen | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Alanine Aminotransferase (ALT) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Aspartate Aminotransferase (AST) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Direct Bilirubin | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Total Bilirubin | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Gamma-glutamyl Transferase (GGT) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change Form Baseline Alkaline Phosphatase (ALP) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Creatinine | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Electrolytes (Na, K, Mg, Cl,Ca, Phosphate) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Trace Elements (Ferritin, Zn, Se, Cu, Mn, Cr) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Glucose | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Total Protein | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline C-reactive Protein (CRP) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline White Blood Cell (WBC) Count | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Red Blood Cell (RBC) Count | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Platelet Count | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Hemoglobin | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Hematocrit | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline International Normalized Ratio (INR) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Change From Baseline Sterols (Beta-sitosterol, Campesterol, Stigmasterol, Brassicasterol, Ergosterol, Cholesterol, Desmosterol, Lanosterol, Beta-sitostanol, Lathosterol, Squalene) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Vital Signs: Blood Pressure | Systolic and diastolic blood pressure | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Vital Signs: Heart Rate | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Vital Signs: Body Temperature | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 monthly to day 365 |
|
|
| Primary | Adverse Events | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | from day 1 weekly to day 365 |
|
|
| Primary | Genetic Polymorphisms of Fatty Acid Desaturase Genes FADS1 and FADS2 | The relation between genetic polymorphisms in the fatty acid desaturase genes Fatty acid desaturase 1 (FADS1) and Fatty acid desaturase 2 (FADS2) and plasma concentrations of linoleic acid, α-linolenic acid, arachidonic acid, docosahexaenoic acid, eicosapentaenoic acid, and Mead acid, as well as relation to and EFAD (triene/tetraene ratio) | Analysis not perfomed due to early study termination. Single subject's data will not be disclosed to maintain confidentiality. | Posted | once during treatment phase (day 1 to day 365) |
|
|
| 0 |
| 1 |
| 1 |
| 1 |
| 1 |
| 1 |
| EG001 | Intralipid, 20% | Intralipid 20% is a sterile, non-pyrogenic fat emulsion intended as a source of calories and essential fatty acids. Intralipid 20% is indicated as a source of calories and essential fatty acids for patients requiring parenteral nutrition for extended periods of time and as a source of essential fatty acids for prevention of essential fatty acid deficiency. The major component fatty acids are linoleic acid, oleic acid, palmitic acid, α-linolenic acid and stearic acid. Intralipid, 20%: The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter. The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour. The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid. Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy. | 0 | 0 | 0 | 0 | 0 | 0 |
| HYPOVOLAEMIC SHOCK | Vascular disorders | Non-systematic Assessment |
|
| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| FUNCTIONAL GASTROINTESTINAL DISORDER | Gastrointestinal disorders | Non-systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | Non-systematic Assessment |
|
| PYREXIA | General disorders | Non-systematic Assessment |
|
| DEVICE RELATED SEPSIS | Infections and infestations | Non-systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | Non-systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
|
| PYREXIA | General disorders | Non-systematic Assessment |
|
| GASTROENTERITIS VIRAL | Infections and infestations | Non-systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Non-systematic Assessment |
|
| LIPASE INCREASED | Investigations | Non-systematic Assessment |
|
| WEIGHT DECREASED | Investigations | Non-systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
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| HYPOCALCAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
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| HYPOKALAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
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| HYPONATRAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
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| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | Non-systematic Assessment |
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| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | Non-systematic Assessment |
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| TETANY | Metabolism and nutrition disorders | Non-systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | Non-systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| HYPOTENSION | Vascular disorders | Non-systematic Assessment |
|
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |