Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-27 @ 10:15 AM
Study NCT ID:
NCT00910104
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2009-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cholestasis Reversal: Efficacy of IV Fish Oil
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002779', 'term': 'Cholestasis'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568345', 'term': 'fish oil triglycerides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark.puder@childrens.harvard.edu', 'phone': '617-355-1838', 'title': 'Mark Puder MD PhD', 'organization': "Boston Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Safety assessment was made from baseline (start of oil-lipid emulsion) until week 38, at which point only one fish oil-lipid emulsion subject was being followed.', 'description': 'Safety assessment was based on comparison of triglycerides (TG), international normalization ratio (INR), and triene-to-tetraene (T/T) ratio. Hypertriglyceridemia was defined as TG\\>400 mg/dL, while INR \\> 2 and T/T ratio \\> 0.2 were deemed abnormally high.', 'eventGroups': [{'id': 'EG000', 'title': 'Omegaven', 'description': '1g/kg/day for duration of study participation for all participants\n\nOmegaven®: 10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated\n\nPlease refer to NDA report that summarizes all adverse events reported to FDA', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 7, 'seriousNumAtRisk': 42, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intralipid', 'description': 'Soybean oil-lipid emulsion, the standard of care lipid emulsion, with fat doses ranging from 1 to 4 g/kg/d.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 17, 'seriousNumAtRisk': 49, 'deathsNumAffected': 12, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypertriglyceridemia', 'notes': 'Triglycerides \\> 400 mg/dL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 56, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'INR > 2.0', 'notes': 'International normalized ratio \\> 2.0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 24, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Essential fatty acid deficiency', 'notes': 'Triene:tetraene ratio \\> 0.2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Omegaven', 'description': '1g/kg/day for duration of study participation for all participants\n\nOmegaven®: 10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated'}, {'id': 'OG001', 'title': 'Intralipid (Historical Control)', 'description': 'Patients who received Intralipid between 1999 and 2006 and whose direct bilirubin was ever \\>=2.0 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '13.9'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '9.7'}]}]}], 'analyses': [{'pValue': '=0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.6', 'ciLowerLimit': '2.0', 'ciUpperLimit': '37.3', 'pValueComment': 'All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\\<0.05 was established as an a priori threshold for statistical significance.', 'groupDescription': 'The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \\[DB\\]\\<=2 mg/dL). Crude (unadjusted) hazard ratios were estimated using proportional hazard regression. Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.4', 'ciLowerLimit': '3.7', 'ciUpperLimit': '83', 'pValueComment': 'All P-values were 2-sided. Analyses were performed in SAS 9.1 (SAS Institute, USA) and S-plus 8 (Insightful, USA). P\\<0.05 was established as an a priori threshold for statistical significance.', 'groupDescription': 'The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \\[DB\\]\\<=2 mg/dL). Adjusted hazard ratios were estimated using proportional hazard regression adjusted for baseline covariates (including duration of parenteral nutrition (PN) and baseline DB). Subjects who died, were transplanted, or still on PN at the end of follow-up were censored (Ref: PMID 19661785).', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Comparison of proportion with reversal of cholestasis (direct bilirubin \\<=2.0 mg/dL).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of treatment', 'description': 'Time to reversal of established parenteral nutrition associated liver disease, defined as a decrease in direct bilirubin to \\<= 2.0 mg/dL.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary efficacy end-point was time to reversal of cholestasis (direct bilirubin \\<= 2.0 mg/dL).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Omegaven', 'description': '1g/kg/day for duration of study participation for all participants.\n\nOmegaven®: 10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.'}, {'id': 'FG001', 'title': 'Intralipid', 'description': 'Intralipid®: 20% Intralipid® up to 3g/kg/day, IV (in the vein).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Between August 2006 and November 2007, 42 patients with IFALD were prospectively enrolled to receive compassionate use open label treatment with 10% FOLE (Omegaven®) as part of their PN. For comparison, retrospective data were retrieved for 49 historical control patients who had received 20% SOLE (Intralipid® 20%) as part of their PN between 1999 and 2006. Patients in both treatment arms were required to have a direct bilirubin level \\>=2mg/dL upon initiation of their respective lipid emulsion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Omegaven', 'description': '1g/kg/day for duration of study participation for all participants\n\nOmegaven®: 10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated'}, {'id': 'BG001', 'title': 'Intralipid (Historical Control)', 'description': 'Patients who received Intralipid between 1999-2006 and whose direct bilirubin was ever \\>=2.0 mg/dL.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and ethnicity not reliably obtained on all subjects.'}, {'title': 'Direct bilirubin', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'BG000', 'lowerLimit': '3.7', 'upperLimit': '8.5'}, {'value': '3.3', 'groupId': 'BG001', 'lowerLimit': '2.9', 'upperLimit': '4.4'}, {'value': '3.9', 'groupId': 'BG002', 'lowerLimit': '3.1', 'upperLimit': '7.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': "Patients who were transferred to Boston Children's after starting Omegaven elsewhere do not have a baseline direct bilirubin available."}, {'title': 'Duration of PN before enrollment (d), median (IQR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '118'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '74'}, {'value': '54', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '90'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Days', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'PN start date is unknown for n=4 in the fish oil-emulsion arm and n=2 in the soybean oil-emulsion arm.'}], 'populationDescription': "Includes subjects treated with Omegaven and subjects who served as historical controls treated with Intralipid. Four participants who were transferred to Boston Children's after starting Omegaven at another institution do not have a baseline direct bilirubin (DB). These same four subjects plus two subjects on Intralipid do not have a PN start date, so duration of PN will be unknown in these cases. Therefore, the sample size for DB will be 38+49=87 and for duration of PN 38+47=85."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-29', 'size': 564109, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-06T10:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2009-05-20', 'resultsFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-19', 'studyFirstPostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reversal of Cholestasis, Defined as a Direct Bilirubin to <= 2.0 mg/dL.', 'timeFrame': 'Duration of treatment', 'description': 'Time to reversal of established parenteral nutrition associated liver disease, defined as a decrease in direct bilirubin to \\<= 2.0 mg/dL.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PNALD', 'Omegaven', 'Parenteral Nutrition Associated Liver Disease', 'Cholestasis', 'Short Bowel Syndrome'], 'conditions': ['Parenteral Nutrition Associated Liver Disease', 'Short Bowel Syndrome', 'Gastrointestinal Disease']}, 'referencesModule': {'references': [{'pmid': '18310188', 'type': 'BACKGROUND', 'citation': 'Gura KM, Lee S, Valim C, Zhou J, Kim S, Modi BP, Arsenault DA, Strijbosch RA, Lopes S, Duggan C, Puder M. Safety and efficacy of a fish-oil-based fat emulsion in the treatment of parenteral nutrition-associated liver disease. Pediatrics. 2008 Mar;121(3):e678-86. doi: 10.1542/peds.2007-2248.'}, {'pmid': '16818533', 'type': 'BACKGROUND', 'citation': 'Gura KM, Duggan CP, Collier SB, Jennings RW, Folkman J, Bistrian BR, Puder M. Reversal of parenteral nutrition-associated liver disease in two infants with short bowel syndrome using parenteral fish oil: implications for future management. Pediatrics. 2006 Jul;118(1):e197-201. doi: 10.1542/peds.2005-2662.'}, {'pmid': '27979360', 'type': 'BACKGROUND', 'citation': "Nandivada P, Anez-Bustillos L, O'Loughlin AA, Mitchell PD, Baker MA, Dao DT, Fell GL, Potemkin AK, Gura KM, Neufeld EJ, Puder M. Risk of post-procedural bleeding in children on intravenous fish oil. Am J Surg. 2017 Oct;214(4):733-737. doi: 10.1016/j.amjsurg.2016.10.026. Epub 2016 Dec 1."}, {'pmid': '27510535', 'type': 'BACKGROUND', 'citation': "Nandivada P, Baker MA, Mitchell PD, O'Loughlin AA, Potemkin AK, Anez-Bustillos L, Carlson SJ, Dao DT, Fell GL, Gura KM, Puder M. Predictors of failure of fish-oil therapy for intestinal failure-associated liver disease in children. Am J Clin Nutr. 2016 Sep;104(3):663-70. doi: 10.3945/ajcn.116.137083. Epub 2016 Aug 10."}, {'pmid': '26962059', 'type': 'BACKGROUND', 'citation': "Nandivada P, Fell GL, Mitchell PD, Potemkin AK, O'Loughlin AA, Gura KM, Puder M. Long-Term Fish Oil Lipid Emulsion Use in Children With Intestinal Failure-Associated Liver Disease [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Aug;41(6):930-937. doi: 10.1177/0148607116633796. Epub 2016 Mar 9."}, {'pmid': '24374535', 'type': 'BACKGROUND', 'citation': "Nandivada P, Chang MI, Potemkin AK, Carlson SJ, Cowan E, O'loughlin AA, Mitchell PD, Gura KM, Puder M. The natural history of cirrhosis from parenteral nutrition-associated liver disease after resolution of cholestasis with parenteral fish oil therapy. Ann Surg. 2015 Jan;261(1):172-9. doi: 10.1097/SLA.0000000000000445."}, {'pmid': '21775562', 'type': 'BACKGROUND', 'citation': 'Le HD, de Meijer VE, Robinson EM, Zurakowski D, Potemkin AK, Arsenault DA, Fallon EM, Malkan A, Bistrian BR, Gura KM, Puder M. Parenteral fish-oil-based lipid emulsion improves fatty acid profiles and lipids in parenteral nutrition-dependent children. Am J Clin Nutr. 2011 Sep;94(3):749-58. doi: 10.3945/ajcn.110.008557. Epub 2011 Jul 20.'}, {'pmid': '19661785', 'type': 'RESULT', 'citation': 'Puder M, Valim C, Meisel JA, Le HD, de Meijer VE, Robinson EM, Zhou J, Duggan C, Gura KM. Parenteral fish oil improves outcomes in patients with parenteral nutrition-associated liver injury. Ann Surg. 2009 Sep;250(3):395-402. doi: 10.1097/SLA.0b013e3181b36657.'}, {'pmid': '34695449', 'type': 'DERIVED', 'citation': 'Gura KM, Calkins KL, Premkumar MH, Puder M. Use of Intravenous Soybean and Fish Oil Emulsions in Pediatric Intestinal Failure-Associated Liver Disease: A Multicenter Integrated Analysis Report on Extrahepatic Adverse Events. J Pediatr. 2022 Feb;241:173-180.e1. doi: 10.1016/j.jpeds.2021.10.030. Epub 2021 Oct 23.'}, {'pmid': '33038344', 'type': 'DERIVED', 'citation': 'Gura KM, Premkumar MH, Calkins KL, Puder M. Fish Oil Emulsion Reduces Liver Injury and Liver Transplantation in Children with Intestinal Failure-Associated Liver Disease: A Multicenter Integrated Study. J Pediatr. 2021 Mar;230:46-54.e2. doi: 10.1016/j.jpeds.2020.09.068. Epub 2020 Oct 8.'}, {'pmid': '32059815', 'type': 'DERIVED', 'citation': 'Gura K, Premkumar MH, Calkins KL, Puder M. Intravenous Fish Oil Monotherapy as a Source of Calories and Fatty Acids Promotes Age-Appropriate Growth in Pediatric Patients with Intestinal Failure-Associated Liver Disease. J Pediatr. 2020 Apr;219:98-105.e4. doi: 10.1016/j.jpeds.2019.12.065. Epub 2020 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).', 'detailedDescription': 'The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven), when used in lieu of the conventional soy-based fat emulsion (Intralipid), is effective in the treatment of parenteral nutrition associated liver disease (PNALD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days\n2. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of \\> 2 mg/dl or currently on Omegaven through another protocol. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.\n3. Direct bilirubin \\> 2.0 mg/dl or already on Omegaven through another protocol\n4. Signed patient informed consent.\n5. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Other causes of chronic liver disease (Hepatitis C, biliary atresia, and alpha 1 anti-trypsin deficiency).\n3. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)\n4. The parent or guardian or child unwilling to provide consent or assent\n\nIn rare instances, patients diagnosed with PNALD may later be found to have liver disease due to other causes in addition to the use of PN (i.e., inborn errors of metabolism, viral infections ). Such causes may not be known at the time of enrollment and will not preclude them from continuing in the study. For the sake of statistical analysis, however, these patients will be excluded although all data will be collected and reviewed.'}, 'identificationModule': {'nctId': 'NCT00910104', 'acronym': 'Reversal', 'briefTitle': 'Cholestasis Reversal: Efficacy of IV Fish Oil', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Cholestasis Reversal: Efficacy of IV Fish Oil', 'orgStudyIdInfo': {'id': '05-04-048'}, 'secondaryIdInfos': [{'id': '1R01FD003460-02', 'link': 'https://reporter.nih.gov/quickSearch/1R01FD003460-02', 'type': 'FDA'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omegaven', 'description': '1g/kg/day for duration of study participation for all participants', 'interventionNames': ['Drug: Omegaven®']}], 'interventions': [{'name': 'Omegaven®', 'type': 'DRUG', 'otherNames': ['Fish Oil Lipid Emulsion (FOLE)'], 'description': '10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated', 'armGroupLabels': ['Omegaven']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mark Puder', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D., Ph.D', 'investigatorFullName': 'Mark Puder', 'investigatorAffiliation': "Boston Children's Hospital"}}}}