Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease
Expanded access is currently available for this treatment.
Verified December 2012 by Children's Hospital of Philadelphia
Sponsor:
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
Maria Mascarenhas, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01297933
First received: February 15, 2011
Last updated: December 14, 2012
Last verified: December 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 15, 2011 | ||||||||
| Last Updated Date | December 14, 2012 | ||||||||
| Start Date ICMJE | January 2011 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01297933 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease | ||||||||
| Official Title ICMJE | Intravenous Omega-3 Fatty Acid (Omegaven) for Pediatric Patients With Total Parenteral Nutrition Associated Liver Dysfunction | ||||||||
| Brief Summary | A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD). |
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| Detailed Description | 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. |
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| Study Type ICMJE | Expanded Access | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Not Provided | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Omegaven
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. |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Available | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Estimated Completion Date | January 2014 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 21 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01297933 | ||||||||
| Other Study ID Numbers ICMJE | 10-007681 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Maria Mascarenhas, Children's Hospital of Philadelphia | ||||||||
| Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Philadelphia | ||||||||
| Verification Date | December 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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