Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-27 @ 7:19 PM
Study NCT ID:
NCT00969332
Status:
TERMINATED
Last Update Posted:
2020-02-26
First Post:
2009-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568345', 'term': 'fish oil triglycerides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KCalkins@mednet.ucla.edu', 'phone': '310-825-9330', 'title': 'Dr. Kara L. Calkins', 'organization': 'UCLA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'early termination because intervention was FDA approved, single site study, prospective observational study, small sample size, change in clinical practice over time'}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 53, 'seriousNumAtRisk': 59, 'deathsNumAffected': 4, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'Hypotension', 'notes': 'Change in blood pressure requiring the use of pressor support', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Distress', 'notes': 'Change in respiratory status requiring intubation or other support.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'notes': 'Serum sodium less than 130', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 37, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertriglyceridemia', 'notes': 'Triglycerides more than 300 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic Acidosis', 'notes': 'potential of hydrogen less than 7.2 and/or requiring medical intervention (volume support, sodium bicarbonate)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bowel Rejection', 'notes': 'Clinical and histological evidence of rejection as well as clinical diagnosis by medical team', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Life Threatening Event', 'notes': 'Diagnosis by clinical team', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 10, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'notes': 'Serum glucose \\< 60 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 247, 'numAffected': 39}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'notes': 'Serum glucose \\>200 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 73, 'numAffected': 24}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'notes': 'Platelet count \\<100,000 cell/cu.mm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 148, 'numAffected': 28}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytosis', 'notes': 'Platelet count \\>500,000 cu.mm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 28, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'notes': 'White blood cell count \\<5000 cells/cu.mm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 106, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased International Normalized Ratio', 'notes': 'International Normalized Ratio \\>1.4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 106, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clinical Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 17, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Sepsis', 'notes': 'Bacteremia, Urosepsis, Fungemia, Viral sepsis - positive culture with symptoms and need for more than 5 days of antibiotics/antifungals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 39, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'notes': 'Platelet count less than 20,000K', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Distress', 'notes': 'Change in respiratory status requiring intubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'notes': 'Hypotension requiring pressor support.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased Creatinine', 'notes': 'Requiring need for dialysis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 31, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bleeding', 'notes': 'Bleeding requiring product replacement or medical intervention (does not include pressure or specific medications) or surgical intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrotizing Enterocolitis', 'notes': 'necrotizing enterocolitis (stage II or III).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'Diagnosis by clinical team', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'notes': 'Diagnosis by clinical team and positive urine culture and need for at least 5 days of antibiotics', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizures', 'notes': 'EEG or clinical diagnosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Reversal of Parenteral Nutrition Associated Cholestasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '5.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'weeks', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'expiration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Underwent a Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'includes isolated liver or multi-visceral transplant including liver graft', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Full Enteral Feeds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '12.49', 'spread': '5.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'discontinuation of parenteral nutrition', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Growth Z-scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.66', 'spread': '1.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Weight Z-scores at the end of the study. Formula used: (weight at end of study-average weight of reference population)/standard deviation of weight of reference population.\n\nThe Z-score indicates the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A weight Z-score \\</= -2 indicates an underweight or malnourished status, while a weight Z-score \\>/= 2 indicates an overweight or obese status.', 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Platelet Counts at the End of the Study - Risk of Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '220.9', 'spread': '134.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'platelet counts at the end of the study', 'unitOfMeasure': 'x10^3 cells/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Essential Fatty Acid Deficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'triene:tetraene ratio less than 0.2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Markers of Inflammation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Serum Cytokines - interleukin-8', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Markers of Sterol Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Serum Phytosterols - stigmasterol', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Markers of Bile Acid Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'spread': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Serum Bile acids - total chenodeoxycholic acid', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Markers of Fatty Acid Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday'}], 'classes': [{'categories': [{'measurements': [{'value': '12.7', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Erythrocyte fatty acid - Docosahexaenoic Acid', 'unitOfMeasure': 'Percent of Sum of Fatty Acids', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omegaven', 'description': 'Omegaven, 0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment for this study began in May 2005. Patients were recruited from the inpatient and outpatient setting at the University of California, Los Angeles.', 'preAssignmentDetails': 'There was no wash-out or run-in period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.\n\nOmegaven: 0.5 gm/kg/d intravenous every day for 2 days, then 1 gm/kg/d intravenous everyday'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '707.9', 'spread': '1366.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '62 subjects were consented for the study. 3 subjects were withdrawn from the study prior to starting the intervention. Hence, 59 subjects started the intervention and baseline characteristics are provided for these 59 subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-12', 'size': 641375, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-01T18:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'whyStopped': 'study intervention was approved by the FDA', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2009-08-31', 'resultsFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2009-08-31', 'lastUpdatePostDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-31', 'studyFirstPostDateStruct': {'date': '2009-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Reversal of Parenteral Nutrition Associated Cholestasis', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'weeks'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '24 weeks, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'expiration'}, {'measure': 'Number of Participants Who Underwent a Transplant', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'includes isolated liver or multi-visceral transplant including liver graft'}, {'measure': 'Time to Full Enteral Feeds', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'discontinuation of parenteral nutrition'}, {'measure': 'Growth Z-scores', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Weight Z-scores at the end of the study. Formula used: (weight at end of study-average weight of reference population)/standard deviation of weight of reference population.\n\nThe Z-score indicates the number of standard deviations away from the mean. A weight Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. A weight Z-score \\</= -2 indicates an underweight or malnourished status, while a weight Z-score \\>/= 2 indicates an overweight or obese status.'}, {'measure': 'Platelet Counts at the End of the Study - Risk of Bleeding', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'platelet counts at the end of the study'}, {'measure': 'Number of Participants With Essential Fatty Acid Deficiency', 'timeFrame': '24 weeks, death, transplant, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'triene:tetraene ratio less than 0.2'}, {'measure': 'Markers of Inflammation', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Serum Cytokines - interleukin-8'}, {'measure': 'Markers of Sterol Metabolism', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Serum Phytosterols - stigmasterol'}, {'measure': 'Markers of Bile Acid Metabolism', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Serum Bile acids - total chenodeoxycholic acid'}, {'measure': 'Markers of Fatty Acid Metabolism', 'timeFrame': '24 weeks, death, or discontinuation of Parenteral Nutrition (whichever comes first)', 'description': 'Erythrocyte fatty acid - Docosahexaenoic Acid'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver', 'parenteral nutrition', 'fish oil', 'omegaven', 'children'], 'conditions': ['Cholestasis']}, 'referencesModule': {'references': [{'pmid': '23894176', 'type': 'RESULT', 'citation': 'Calkins KL, Dunn JC, Shew SB, Reyen L, Farmer DG, Devaskar SU, Venick RS. Pediatric intestinal failure-associated liver disease is reversed with 6 months of intravenous fish oil. JPEN J Parenter Enteral Nutr. 2014 Aug;38(6):682-92. doi: 10.1177/0148607113495416. Epub 2013 Jul 26.'}, {'pmid': '28521607', 'type': 'RESULT', 'citation': 'Calkins KL, DeBarber A, Steiner RD, Flores MJ, Grogan TR, Henning SM, Reyen L, Venick RS. Intravenous Fish Oil and Pediatric Intestinal Failure-Associated Liver Disease: Changes in Plasma Phytosterols, Cytokines, and Bile Acids and Erythrocyte Fatty Acids. JPEN J Parenter Enteral Nutr. 2018 Mar;42(3):633-641. doi: 10.1177/0148607117709196. Epub 2017 Dec 18.'}, {'pmid': '30411372', 'type': 'RESULT', 'citation': 'Wang C, Venick RS, Shew SB, Dunn JCY, Reyen L, Gou R, Calkins KL. Long-Term Outcomes in Children With Intestinal Failure-Associated Liver Disease Treated With 6 Months of Intravenous Fish Oil Followed by Resumption of Intravenous Soybean Oil. JPEN J Parenter Enteral Nutr. 2019 Aug;43(6):708-716. doi: 10.1002/jpen.1463. Epub 2018 Nov 8.'}, {'pmid': '30900274', 'type': 'RESULT', 'citation': 'Ong ML, Venick RS, Shew SB, Dunn JCY, Reyen L, Grogan T, Calkins KL. Intravenous Fish Oil and Serum Fatty Acid Profiles in Pediatric Patients With Intestinal Failure-Associated Liver Disease. JPEN J Parenter Enteral Nutr. 2019 Aug;43(6):717-725. doi: 10.1002/jpen.1532. Epub 2019 Mar 22.'}, {'pmid': '32072161', 'type': 'DERIVED', 'citation': 'Calkins KL, Thamotharan S, Ghosh S, Dai Y, Devaskar SU. MicroRNA 122 Reflects Liver Injury in Children with Intestinal Failure-Associated Liver Disease Treated with Intravenous Fish Oil. J Nutr. 2020 May 1;150(5):1144-1150. doi: 10.1093/jn/nxaa001.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate if intravenous fish oil, commercially available as Omegaven, safely and effectively reverses parenteral nutrition associated cholestasis in children.', 'detailedDescription': 'Infants dependent on parenteral nutrition for greater than 1 year who develop parenteral nutrition associated cholestasis will universally face mortality unless they receive a timely liver and/or small bowel transplant. Although transplant survival has improved in recent years, survival is not guaranteed, and transplant care remains costly. Alternative nutritional and pharmacological strategies are imperative to improve the clinical outcomes of infants with intestinal failure and parenteral nutrition associated cholestasis. In both animal and human studies, intravenous fish oil, a lipid emulsion rich in omega-3 fatty acids and Vitamin E, and lacking phytosterols, has been shown to ameliorate parenteral nutrition associated cholestasis and improve morbidity and mortality. The purpose of this pilot study is to investigate if Omegaven, a commercially available intravenous fish oil, at 1 g/kg/d, will safely reverse liver disease in 80 subjects with parenteral nutrition associated cholestasis. Subjects can initially receive a maximum of 6 months (24 weeks) of intravenous fish oil. If the subject re-develops liver disease and still satisfies inclusion/exclusion criteria, the intervention can be restarted. Study subjects will be compared to a historical cohort of children with Short Bowel Syndrome and parenteral nutrition associated cholestasis who have been receiving standard intravenous soybean oil for \\> 60 days. The fish oil cohort will be followed for a total of 5 years to determine if transplant-free mortality is reduced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical evidence of parenteral nutrition associated cholestasis\n* Direct bilirubin greater or equal to 2 mg/dL on 2 consecutive measurements\n* Expected parenteral nutrition course greater than 30 days\n* Acquired or congenital gastrointestinal disease\n* \\> 2 weeks of age and \\< 18 years of age\n* \\> 60% calories from parenteral nutrition\n* Failed standard therapies to prevent progression of liver disease (Actigal, cyclic parenteral nutrition, avoidance of overfeeding, reduction/removal of copper from parenteral nutrition if elevated my laboratory analysis, advancement of enteral feeds)\n\nExclusion Criteria:\n\n* Inborn errors of metabolism\n* Extracorporeal Membrane Oxygenation\n* Seafood, egg, or Omegaven allergy\n* Documented case of liver disease other than Parenteral Nutrition Associated Cholestasis\n* Hemorrhagic disorder\n* Anticoagulant therapy\n* Hemodynamically unstable or in shock\n* Comatose state\n* Stroke, pulmonary embolism, recent myocardial infarction\n* Diabetes\n* Fatal chromosomal disorder\n* Enrollment in any other clinical trial involving an investigational agent\n* Patient, parent, or legal guardians unable or unwilling to give consent\n* Patient expected to be weaned from parenteral nutrition in 30 days\n* unable to tolerate necessary monitoring\n* Patient requiring aspirin or toradel or motrin\n* Patient requiring dialysis'}, 'identificationModule': {'nctId': 'NCT00969332', 'acronym': 'FO', 'briefTitle': 'A Safety and Efficacy Study to Determine if Giving Intravenous Fish Oil Helps Children With Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Omegaven and Parenteral Nutrition Associated Cholestasis', 'orgStudyIdInfo': {'id': '09-02-079-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omegaven', 'description': '0.5 g/kg/d IV x 2 days, then 1 g/kg/d IV for 24 weeks or until parenteral nutrition discontinuation, death or transplant, whichever comes first. Subjects are eligible to restart Omegaven should they re-satisfy inclusion/exclusion criteria.', 'interventionNames': ['Drug: Omegaven']}], 'interventions': [{'name': 'Omegaven', 'type': 'DRUG', 'description': '0.5 g/kg/d intravenous every day for 2 days, then 1 g/kg/d intravenous everyday', 'armGroupLabels': ['Omegaven']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Kara L Calkins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kara L. Calkins, MD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}