Clinical Trial: Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome: Reduction in Conjugated/Direct Bilirubin [ Time Frame: 14 weeks ]

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®.


Original Primary Outcome: Reduction in Conjugated Bilirubin [ Time Frame: 14 weeks ]

Primary endpoint - reduction in conjugated bilirubin level to below 1 mg/dl. Previous studies suggest that conjugated 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 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®.


Current Secondary Outcome: Normalization of total bilirubin and liver enzymes [ Time Frame: 14 weeks ]

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.


Original Secondary Outcome: Normalization of total bilirubin and liver enzymes [ Time Frame: 14 weeks ]

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 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.


Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: July 29, 2010
Date Started: July 2010
Date Completion: July 2025
Last Updated: April 26, 2017
Last Verified: April 2017