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This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm OMEGAVEN® (fish oil triglycerides; injectable emulsion) | The dose of investigational drug (study treatment), as well as all other components of the overall nutritional regimen is solely at the discretion of the Investigator. It is assumed the Investigator will use sound medical judgement, follow institutional standards of care regarding the nutrition provided to each patient, and review applicable prescribing information indicating the maximum and recommended dose of Omegaven of 1 g/kg/day infused intravenously over 8 to 24 hours as long as the infusion rate does not exceed 1.5 mL/kg/hour. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omegaven® (fish oil triglycerides) Injectable Emulsion | Drug | Pediatric patients Pediatric patients with new-onset PNAC Drug: Omegaven® (fish oil triglycerides) Injectable Emulsion Dose, frequency and duration is a decision of the Investigator |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of essential fatty acid deficiency (EFAD) | EFAD as defined by the triene:tetraene (T:T) ratio; severity of EFAD will be graded and analysed based on T:T ratio (suspected ≥ 0.05, moderate ≥ 0.20, and severe ≥ 0.40) | Up to week 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinical EFAD | Clinical EFAD is defined by clinical symptoms (like dry, scaly rash, hair loss, hair depigmentation, poor wound healing, growth restriction, and increased susceptibility to infection) and T:T ratio ≥ 0.083 | Up to week 56 |
| Time from treatment start to EFAD diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female pediatric patients with PNAC and expected requirement of Omegaven for at least 8 weeks will be enrolled at multiple sites; PNAC is defined as being PN-dependent with a DBil level ≥ 2.0 mg/dL and no other known cause of liver dysfunction.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niess Ulf, PhD | Contact | M +49 173 5439924 | ulf.niess@fresenius-kabi.com | |
| Lohse Jean-Marc, PhD | Contact | +49 173 5420453 | Jean-Marc.Lohse@fresenius-kabi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Health Service | Recruiting | Fountain Valley | California | 92708 | United States | |
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Time from treatment start to EFAD diagnosis |
| Up to week 56 |
| Incidence of adverse events (AEs)/serious adverse events (SAEs) | The incidence of AEs/SAEs considered by the Investigator to be related to study treatment | Up to week 56 |
| Routine laboratory tests: Direct or conjugated bilirubin | Up to week 56 |
| Routine laboratory tests: triglycerides | Up to week 56 |
| Fatty acid profiles: α-linolenic acid | Up to week 56 |
| Fatty acid profiles: linoleic acid | Up to week 56 |
| Fatty acid profiles: arachidonic acid | Up to week 56 |
| Fatty acid profiles: mead acid | Up to week 56 |
| Fatty acid profiles: oleic acid | Up to week 56 |
| Fatty acid profiles: docosahexaenoic acid (DHA) | Up to week 56 |
| Fatty acid profiles: eicosapentaenoic acid (EPA) | Up to week 56 |
| Anthropometric measures: body weight | Up to week 56 |
| Anthropometric measures: body height/length | Up to week 56 |
| Anthropometric measures: head circumference | Up to week 56 |
| University of California Los Angeles |
| Recruiting |
| Los Angeles |
| California |
| 10911 |
| United States |
| The University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| Children's Hospital Corporation d/b/a Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Board of Regents of the University of Oklahoma Health Sciences Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
| Baylor College of Medicine Houston | Recruiting | Houston | Texas | 77030 | United States |
| The University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229-3901 | United States |
| Seattle Children's Hospital d/b/a Seattle Children's Research Institute | Recruiting | Seattle | Washington | 98105 | United States |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C568345 | fish oil triglycerides |
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