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Trial record 9 of 582 for:    bilirubin AND liver function

Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury

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: NCT02010034
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Nandini Channabasappa, MD, Children's Medical Center Dallas

Brief Summary:
This study is being done to determine if an investigational study drug called Omegaven can help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth.

Condition or disease Intervention/treatment Phase
Liver Disease Impaired Liver Function Parenteral Nutrition Associated Liver Disease Drug: Omegaven Not Applicable

Detailed Description:
PAtients with direct bilirubin >2gm/dL and short bowel syndrome are eligible for enrollment. Omegaven at 1gm/kg/day will be administered via central venous line instead of standard lipid preparations.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury
Study Start Date : August 2013
Actual Primary Completion Date : February 5, 2019
Actual Study Completion Date : February 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Compassionate use
This lipid preparation is only being used for compassionate use.
Drug: Omegaven
Omegaven will be used in place of soy oil Intralipid




Primary Outcome Measures :
  1. Bilirubin in mg/dL [ Time Frame: 12 weeks ]

    PN associated liver disease can be reversed or its progression halted by using a parenteral fat emulsion prepared from fish oil as measured by normalization of serum levels of hepatic enzymes and bilirubin

    1. after reaching bilirubin levels >2mg/dl, subjects receiving Omegaven will reach a bilirubin level < 2mg/dL faster that patients receiving conventional fat emulsions.



Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 weeks ]

    a. After starting Omegaven on PN, the rate of fatty acid deficiencies and imbalances will be as low as before Omegaven. Also, the rate of triglyceride events >400mg/dL with Omegaven will be similar to that seen with PN administration with soy oil Intralipid.

    B. PN containing Omegaven will be safe for patients with respect to the risk of unexpected bleeding, coagulopathies, and other adverse events.




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Ages Eligible for Study:   2 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be 2 months -10 years of age
  2. Patients who are PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
  3. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined by a direct bilirubin of >2.0mg/dL. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment
  4. 2 consecutive direct bilirubin test results >2.0mg/dl
  5. The patient must have failed standard therapies to prevent the progression of liver disease such as surgical treatment, cyclic TPN, avoiding overfeeding, reduction/removal of copper and manganese from TPN, advancement of enteral feeding, and use of ursodiol (Actigall)
  6. Subjects who are currently under treatment for PNALD with Compassionate Use Omegaven and have a direct Bilirubin of< 2, but who remain TPN dependent and require continued therapy with Omegaven

Exclusion Criteria:

  1. Other known causes of chronic liver disease (hepatitis C, cystic fibrosis, biliary atresia and alpha 1 anti-trypsin deficiency)
  2. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
  3. The parent, guardian, or child is unwilling to provide consent or assent
  4. Allergy to any fish product, egg protein, and/or previous allergy to Omegaven
  5. Active coagulopathies characterized by on-going bleeding or by a requirement for clotting factor replacement such as fresh frozen plasma or cryoprecipitate to maintain homeostasis
  6. Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis
  7. Unstable diabetes mellitus
  8. Stroke/embolism
  9. Collapse and shock
  10. Undefined coma status
  11. Active infection at time of initiation of Omegaven® up until such time as child is afebrile with stable vital signs and one negative 48 hour culture

Information from the National Library of Medicine

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): NCT02010034


Locations
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United States, Texas
Children's Medical Center of Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Children's Medical Center Dallas
Investigators
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Principal Investigator: Nandini Channabasappa, MD Childrens Health

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Responsible Party: Nandini Channabasappa, MD, Director, Intestinal Rehabilitation Program, Children's Medical Center Dallas
ClinicalTrials.gov Identifier: NCT02010034     History of Changes
Other Study ID Numbers: STU 112010-159
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

Keywords provided by Nandini Channabasappa, MD, Children's Medical Center Dallas:
TPN
Liver Function
parenteral nutritional fat emulsions

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases