Compassionate Use of Omegaven IV Fat Emulsion
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|ClinicalTrials.gov Identifier: NCT01323907|
Recruitment Status : Withdrawn (Omegaven is now FDA approved.)
First Posted : March 28, 2011
Last Update Posted : February 6, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Total Parenteral Nutrition-induced Cholestasis||Drug: Omegaven IV lipid emulsion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compassionate Use of Omegaven IV Fat Emulsion in Infants With Life Threatening Parenteral Nutrition-associated Liver Disease (PNALD).|
|Estimated Study Start Date :||January 2011|
|Actual Primary Completion Date :||February 13, 2019|
|Actual Study Completion Date :||February 13, 2019|
Omegaven IV lipid emulsion administration for infants with life threatening parenteral nutrition associated liver disease
Drug: Omegaven IV lipid emulsion
For infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/kg/day and is infused over 24 hours for 1-2 days and then advanced to 1 gram/kg/day. Omegaven will be infused intravenously through a central or peripheral catheter alone or in conjunction with parenteral nutrition.
Other Name: Omega-3 Fatty Acids
- Reduction of direct serum bilirubin level (mg/dL) [ Time Frame: Up to 6 months from the completion of the study. ]For effectiveness endpoint, the allowable minimum time interval between serial direct bilirubin measurements that will determine reversal of cholestasis is 2 consecutive measurements of direct bilirubin < or = to 2mg/dL obtained at least 2 weeks apart.
- Essential fatty acid profile [ Time Frame: Up to 30 days from therapy completion ]Previous studies have found no association between Omegaven administration and essential fatty acid deficiency. Due to theoretical concern for developing fatty acid deficiency with low dose Omegaven administration, these levels will be followed during Omegaven therapy.
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|Ages Eligible for Study:||2 Months to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Diagnosis of life threatening PNALD
- Dependent on Parenteral Nutrition for caloric needs
- Expected to require PN for at least another 30 days
- Other causes of liver disease have been excluded
- GI/Liver service is involved in patient care
- Standard therapies for the treatment of PNALD must have been utilized prior to initiating omegaven.
- Inpatient at Morgan Stanley Children's Hospital of NewYork Presbyterian Hospital
- Must be at least 2 months of age
- Not inpatient
- Younger than 2 months of age
- Expected to be weaned off of parenteral nutrition within 30 days
- have other documented causes of liver disease
- have signs of proven severe advanced liver disease
- Allergy to seafood, egg protein and/or previous allergy to Omegaven
- active coagulopathy, impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis, stoke, embolism, hemodynamic collapse or shock, recent MI, cholestasis due to any reason other than PNALD, active new infection at time of initiation of Omegaven, hemodynamic instability or if unable to tolerate the necessary laboratory monitoring
- must not be enrolled in another clinical trial involving an investigational agent (unless approved by the designated physicians).
- Parent or legal guardian must be willing to provide consent.
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): NCT01323907
|United States, New York|
|Columbia Presbyterian Medical Center-Children's Hospital of NY|
|New York, New York, United States, 10032|
|Principal Investigator:||Sivan Kinberg, MD, MS||Columbia University|
|Responsible Party:||Sivan Kinberg, Assistant Professor of Pediatrics at the Columbia University Medical Center, Columbia University|
|Other Study ID Numbers:||
|First Posted:||March 28, 2011 Key Record Dates|
|Last Update Posted:||February 6, 2020|
|Last Verified:||February 2020|
Total Parenteral Nutrition-induced Cholestasis
Digestive System Diseases
Bile Duct Diseases
Biliary Tract Diseases