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To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).
This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall Study | Experimental | Use of Omegaven for patients with parenteral nutrition associated liver disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omegaven | Drug | Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression as Measured by Serum Levels of Hepatic Enzymes | To evaluate whether established parenteral nutrition associated liver disease (PNALD) can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) as measured by normalization or decrease of serum levels of hepatic enzymes. | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel D Lim, MD | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | Use of Omegaven for patients with parenteral nutrition associated liver disease. Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Use of Omegaven for patients with parenteral nutrition associated liver disease. Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Disease Progression as Measured by Serum Levels of Hepatic Enzymes | To evaluate whether established parenteral nutrition associated liver disease (PNALD) can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) as measured by normalization or decrease of serum levels of hepatic enzymes. | No results recorded, study was utilized to provide compassionate use of study medication to participants. | Posted | Up to 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study | Use of Omegaven for patients with parenteral nutrition associated liver disease. Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joel Lim, MD - Principal Investigator | Children's Mercy Hospital | (816)234-3000 | jlim@cmh.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2012 | Jan 7, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| C568345 | fish oil triglycerides |
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This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND.
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|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 2 |
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| 2 |
| 0 |
| 2 |
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