Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better. It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis|
- Reduction in Conjugated/Direct Bilirubin [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]Primary endpoint - reduction in conjugated/direct bilirubin level to below 1 mg/dl. Previous studies suggest that conjugated/direct bilirubin will remain elevated for approximately 8 weeks. Subsequently, levels are expected to fall by approximately 1 mg/dl/week until they normalize. A patient who begins Omegaven® with a conjugated/direct bilirubin level of 7 mg/dl is likely to experience normalization within 14 weeks (8+6 weeks). We will compare the group receiving Omegaven® with historical controls from our internal registry who have demonstrated cholestasis while on Intralipid®.
- Normalization of total bilirubin and liver enzymes [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]Secondary endpoints will be: normalization of total bilirubin and liver enzymes. Differences in these values at the end of 14 weeks of therapy will be compared with those of controls via Kaplan-Meier analysis identical to that employed for conjugated/direct bilirubin levels. Furthermore, we expect that elevated triglyceride levels which might be present at the initiation of therapy will have normalized at the same time that liver profiles have normalized.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2025|
|Estimated Primary Completion Date:||July 2025 (Final data collection date for primary outcome measure)|
Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require TPN or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site.
Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173159
|Contact: Crystal Slaughter, BAemail@example.com|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Crystal Slaughter, BA 513-636-0137 firstname.lastname@example.org|
|Principal Investigator: Samuel A Kocoshis, MD|
|Principal Investigator:||Samuel Kocoshis, MD||Children's Hospital Medical Center, Cincinnati|