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The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.
Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omegaven | Experimental | Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omegaven | Drug | For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Change in Conjugated/Direct Bilirubin | Change in conjugated/direct bilirubin level to below 1 mg/dl. | Completion of Therapy (time frame from 1-14 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Change in Unconjugated/Total Bilirubin | Change in unconjugated/total bilirubin level to below 1.1 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Completion of Therapy (time frame from 1-14 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
Any of the contraindications to use of Omegaven®
Impaired lipid metabolism (triglycerides >1000 mg/dL) while on
1g/kg/day or less of Intralipid
History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
Unstable diabetes mellitus
Collapse and shock
Stroke/ Embolism
Cardiac infarction within the last 3 months
Undefined coma status
Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential
Females of child-bearing potential who are unwilling to use birth control during study participation
Parental decision to forego the use of Omegaven®
Known fish or egg allergy
Pregnancy
Causes of liver disease other than Parenteral Nutrition Associated Cholestasis
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Kocoshis, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omegaven | Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids. Omegaven: For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omegaven | Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require TPN or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids. Omegaven: For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site. |
| 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 | Number of Participants With a Change in Conjugated/Direct Bilirubin | Change in conjugated/direct bilirubin level to below 1 mg/dl. | Posted | Count of Participants | Participants | Completion of Therapy (time frame from 1-14 weeks) |
|
1 to 14 weeks of therapy
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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 | Omegaven | Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require TPN or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids. Omegaven: For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | General disorders | CTCAE (4.0) | Non-systematic Assessment |
We enrolled very few patients so that we have too small a cohort with which to assess achievement of our outcomes.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Crystal Slaughter, BA, CCRC | Cincinnati Children's Hospital Medical Center | 513-636-0137 | crystal.slaughter@cchmc.org |
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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 | Feb 2, 2015 | Mar 12, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| C568345 | fish oil triglycerides |
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|
| Number of Participants With a Change in Aspartate Transaminase (AST) | Change in aspartate transaminase (AST) 57 units/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Completion of Therapy (time frame from 1-14 weeks) |
| Number of Participants With a Change in Liver Enzyme (ALT) | Change in liver enzyme ALT to below 59 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Completion of Therapy (time frame from 1-14 weeks) |
| Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase | Change in liver enzyme alkaline phosphatase to below 345 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Completion of Therapy (time frame from 1-14 weeks) |
| Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT) | Change in Liver Enzyme Gamma-glutamyltransferase (GGT) to below 15 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Completion of Therapy (time frame from 1-14 weeks) |
| Number of Participants With a Change in Triglycerides | Change in Triglycerides to below 119 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Completion of Therapy (time frame from 1-14 weeks) |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With a Change in Unconjugated/Total Bilirubin | Change in unconjugated/total bilirubin level to below 1.1 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Posted | Count of Participants | Participants | Completion of Therapy (time frame from 1-14 weeks) |
|
|
|
| Secondary | Number of Participants With a Change in Aspartate Transaminase (AST) | Change in aspartate transaminase (AST) 57 units/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Posted | Count of Participants | Participants | Completion of Therapy (time frame from 1-14 weeks) |
|
|
|
| Secondary | Number of Participants With a Change in Liver Enzyme (ALT) | Change in liver enzyme ALT to below 59 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Posted | Count of Participants | Participants | Completion of Therapy (time frame from 1-14 weeks) |
|
|
|
| Secondary | Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase | Change in liver enzyme alkaline phosphatase to below 345 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Posted | Count of Participants | Participants | Completion of Therapy (time frame from 1-14 weeks) |
|
|
|
| Secondary | Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT) | Change in Liver Enzyme Gamma-glutamyltransferase (GGT) to below 15 unit/L. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Posted | Count of Participants | Participants | Completion of Therapy (time frame from 1-14 weeks) |
|
|
|
| Secondary | Number of Participants With a Change in Triglycerides | Change in Triglycerides to below 119 mg/dL. General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes. | Posted | Count of Participants | Participants | Completion of Therapy (time frame from 1-14 weeks) |
|
|
|
| 0 |
| 10 |
| 4 |
| 10 |
| 6 |
| 10 |
| Acute Kidney Injury | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Compartment Syndrome Following Surgery | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hyperkalemia Causing Cardiac Dysrhythmia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cardiac Arrest | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastrointestinal Hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Multisystem Organ Dysfunction related to IPEX | Congenital, familial and genetic disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Upper Respiratory Infection | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Phosporus Decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
|
| Skin Irritation and breakdown | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Diaper Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Pulmonary Vein Stenosis | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gastrointestinal Fistula | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Blood in Stool | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Portal Hypertension | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Ventricular Tachycardia | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Irritability | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dried blood near Anus | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tachycardia and Tachypnea | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Culture Positive from Tracheostomy | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Triglycerides Increased | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Gull bladder sludge with intrahepatice biliary ductal dilation | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Activated Partial Throboplastin Time Prolonged | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Lethargy | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Platelet Count Decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Nasal Congestion | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Cough | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Decreased Respiratory Rate | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Bleeding from nose | Hepatobiliary disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Abnormal CBC Differential with Active Bleeding | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |