Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-30 @ 5:35 PM
Study NCT ID:
NCT01425567
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2019-02-12
First Post:
2011-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'statusVerifiedDate': '2019-01', 'lastUpdateSubmitDate': '2019-02-11', 'studyFirstSubmitDate': '2011-08-03', 'studyFirstSubmitQcDate': '2011-08-29', 'lastUpdatePostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['cholestasis', 'parenteral nutrition'], 'conditions': ['Liver Disease']}, 'referencesModule': {'references': [{'pmid': '28437326', 'type': 'DERIVED', 'citation': 'Sorrell M, Moreira A, Green K, Jacob R, Tragus R, Keller L, Quinn A, McCurnin D, Gong A, El Sakka A, Mittal N, Blanco C. Favorable Outcomes of Preterm Infants With Parenteral Nutrition-associated Liver Disease Treated With Intravenous Fish Oil-based Lipid Emulsion. J Pediatr Gastroenterol Nutr. 2017 May;64(5):783-788. doi: 10.1097/MPG.0000000000001397.'}]}, 'descriptionModule': {'briefSummary': 'To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.', 'detailedDescription': 'Patients who meet the inclusion criteria (having a direct bilirubin ≥4.0 mg/dL) and are consented will be discontinued from standard soybean-based lipid emulsion and started on Omegaven®. Omegaven® will be infused continuously via either a peripheral or central catheter at a dose of 1 gm/kg/day along with parenteral nutrition (PN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '14 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n\\- \\>14 days \\<24 months\\* Anatomic short gut (\\< 50 % bowel removed) with total bilirubin \\> or = 4 mg/dL Or severe dysmotility of gut reflecting non functional gut with total bilirubin \\> or = 4 mg/dL Receiving at least 60 % calories by intravenous infusion Requires IV nutrition an additional 28 days \\* Patients with direct bilirubin \\> or = 6 mg/dL who do not meet criteria above but meet criteria with \\* If infants qualify for high risk ARM (gastroschisis, ileal atresia, \\<750 grams and stage III NEC) d bilirubin \\>1 mg/dL but less than 4 mg/dL.\n\nExclusion Criteria:\n\nCongenital lethal condition (e.g. Trisomy 13) Clinically severe bleeding Evidence of viral hepatitis or primary liver disease as etiology of their cholestasis Other health problems such as survival extremely unlikely even if cholestasis improves Known allergies to eggs or shellfish'}, 'identificationModule': {'nctId': 'NCT01425567', 'acronym': 'Omegaven', 'briefTitle': 'Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'Compassionate Use of an Intravenous Lipid Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Children', 'orgStudyIdInfo': {'id': 'HSC2011-0211T'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intravenous Lipid Emulsion Comprised of Fish Oil', 'type': 'DRUG', 'otherNames': ['Omegaven'], 'description': 'IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease'}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University Health System', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Cynthia Blanco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}