Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-26 @ 5:58 AM
Study NCT ID:
NCT02121769
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-04-10
First Post:
2014-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omegaven Expanded Access Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D012778', 'term': 'Short Bowel Syndrome'}], 'ancestors': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568345', 'term': 'fish oil triglycerides'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2019-04', 'lastUpdateSubmitDate': '2019-04-08', 'studyFirstSubmitDate': '2014-04-21', 'studyFirstSubmitQcDate': '2014-04-23', 'lastUpdatePostDateStruct': {'date': '2019-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['cholestasis', 'short bowel syndrome'], 'conditions': ['Parenteral Nutrition Associated Liver Disease']}, 'descriptionModule': {'briefSummary': 'Omegaven is an intravenous fat emulsion (IFE) comprised of omega-3 fatty acids derived from fish oil. It will be used in an open label compassionate use treatment protocol, as an alternative to soybean oil (omega-6), as the sole IFE source of parenteral nutrition in an effort to reduce and/or reverse parenteral nutrition associated liver disease. The study will evaluate the safety and efficacy of Omegaven use in pediatric patients with PN dependence and PNALD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of ≥ 2 mg/dL on the last two consecutive bilirubins while on PN. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.\n* Failed standard/conventional therapies to prevent progression of PNALD.\n* Age newborn to 17 years of age\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Allergy to eggs and/or shellfish\n* Female who is pregnant or lactating\n* Severe hemorrhagic disorder\n* Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency,)\n* 18 years of age or older\n* Parent/legally authorized representative is unwilling to consent.'}, 'identificationModule': {'nctId': 'NCT02121769', 'briefTitle': 'Omegaven Expanded Access Protocol', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's Health System, Boise, Idaho"}, 'officialTitle': 'Protocol for Patients With Parenteral Nutrition Associated Liver Disease (PNALD) to Access Parenteral Fish Oil (Omegaven®) - Omegaven IND 122375', 'orgStudyIdInfo': {'id': 'Omegaven Expanded Access'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Omegaven', 'type': 'DRUG', 'description': '10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': "St. Luke's Pediatric Gastroenterology", 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}], 'overallOfficials': [{'name': 'Tyler Burpee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pediatric Gastroenterology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's Health System, Boise, Idaho", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tyler Burpee, MD', 'investigatorAffiliation': "St. Luke's Health System, Boise, Idaho"}}}}