Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01173159|
Recruitment Status : Completed
First Posted : July 30, 2010
Last Update Posted : February 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cholestasis||Drug: Omegaven||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||December 2018|
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.
- 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®.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173159
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Samuel Kocoshis, MD||Children's Hospital Medical Center, Cincinnati|