Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
|ClinicalTrials.gov Identifier: NCT01325584|
Recruitment Status : Terminated (Alternative product is now approved and available for use.)
First Posted : March 30, 2011
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Hepatic Injury||Drug: Omegaven||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||April 2017|
Experimental: Omegaven (compassionate use)
This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.
initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.
Other Name: fish oil
- Maximum conjugated bilirubin [ Time Frame: up to 4 weeks ]
- Time to resolution of bilirubin or time to death [ Time Frame: up to 4 weeks ]to be summarized as incidence and if there is sufficient data may also be presented as time to resolution.
- average improvement in bilirubin, alkaline phosphatase, AST, and ALT [ Time Frame: up to 4 weeks ]lab values will be summarized at baseline and as change from baseline to worst follow-up value.
- Adverse Events reported for each patient [ Time Frame: up to 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325584
|United States, Illinois|
|Cancer Treatment Centers of America at Midwestern Regional Medical Center|
|Zion, Illinois, United States, 60099|
|Principal Investigator:||Pankaj Vashi, MD||Midwestern Regional Medical Center|