Trial record 13 of 1050 for:
Open Studies | "Nutrition"
Safer Parenteral Nutrition in Pediatric Short Bowel Syndrome to Decrease Liver Damage
Expanded access is currently available for this treatment.
Verified January 2014 by Georgetown University
Information provided by (Responsible Party):
First received: May 22, 2013
Last updated: March 12, 2015
Last verified: January 2014
To provide children dependent on total parenteral nutrition with Omegaven®, a fish oil-based intravenous lipid emulsion that may be less hepatotoxic than conventional, vegetable oil-based intravenous lipid emulsions, and that may therefore reduce the need for liver transplantation.
Cholestasis of Parenteral Nutrition
Drug: Omegaven 10%
What is Expanded Access?
||A Safer Approach to Total Parenteral Nutrition in Pediatric Short Bowel Syndrome Intended to Decrease the Frequency and Severity of Liver Damage
Drug: Omegaven 10%
Patients with a sustained TPN requirement due to short bowel syndrome and TPN-associated liver disease that threatens progression to liver failure and death, for which the only available means of prevention at present is timely liver and/or intestinal transplant.
Omegaven 10%, 1 gram/kg, IV, every 12 hours until transplantation, or stopping TPN
|Ages Eligible for Study:
||2 Months to 18 Years
|Genders Eligible for Study:
The targeted population for enrollment is the cohort of patients with TPN-dependent short bowel syndrome, defined as any pediatric patient who, following abdominal surgery, has a residual small bowel length less than 25% of that predicted for gestational age or requires postoperative TPN for more than 42 days because of gastrointestinal intolerance and who has developed TPN-associated liver disease sufficient to pose a significant risk for progression to liver failure based on the following criteria:
- Total serum bilirubin concentration greater than 3 mg/dL after a total duration of TPN greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks.
• Platelet count less than 200,000/μL after a total duration of TPN greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks.
• Serum albumin concentration less than 3.2 mg/dL after a total duration of TPN greater than 2 months in the absence of a proven episode of bacteremia within the preceding 3 weeks.
Patients with coagulopathy due to parenteral nutrition-associated liver disease (INR > 1.2) will be potential candidates for enrollment, because patients with an elevated INR exceeding 2 have demonstrated resolution of coagulopathy after treatment with Omegaven®.11 Similarly, patients with hyperlipidemia will be potential candidates for enrollment.
Alternatively, patients currently receiving Omegaven that was initiated at another center because of intestinal failure with liver disease that do not need to meet the lab criteria listed above. The subject may continue Omegaven under this protocol at the discretion of the Principle Investigator.
Patients with a history of the following will be excluded from enrollment in this protocol:
- Allergy to fish or egg protein.
- Liver disease proven or suspected to be caused by a process other than TPN-dependent short bowel syndrome, including but not limited to hepatitis C, hepatitis B, cystic fibrosis, biliary atresia, Alagille syndrome, familial intrahepatic cholestasis, and alpha-1-antitrypsin deficiency.11
- Refusal of third party providers to reimburse hospital for the cost of Omegaven®.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01861834
|Contact: Stuart S. Kaufman, MD
|MedStar Georgetown Transplant Institute
|Washington, District of Columbia, United States, 20007 |
|Principal Investigator: Stuart Kaufman, MD |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 22, 2013
||March 12, 2015
||United States: Food and Drug Administration
Keywords provided by Georgetown University:
Short Bowel Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 25, 2015
Short Bowel Syndrome
Digestive System Diseases