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Omegaven as Alternative Parenteral Fat Nutrition

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: NCT03662282
Recruitment Status : Completed
First Posted : September 7, 2018
Results First Posted : July 22, 2020
Last Update Posted : July 22, 2020
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Brief Summary:
To provide Omegaven® as a compassionate treatment for critically ill infants with parenteral nutrition associated cholestasis

Condition or disease Intervention/treatment Phase
Cholestasis Cholestasis of Parenteral Nutrition Drug: Omegaven Phase 3

Detailed Description:
An intermediate population, Investigational New Drug study, to provide an alternate intravenous fat nutrition, Omegaven®, to help improve liver function while providing adequate nutrition for critically ill infants with parenteral nutrition associated cholestasis

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omegaven as Alternative Parenteral Fat Nutrition
Actual Study Start Date : October 23, 2018
Actual Primary Completion Date : January 7, 2019
Actual Study Completion Date : January 7, 2019

Arm Intervention/treatment
Experimental: Drug - Omegaven®
Therapy with Omegaven® will be initiated at the goal dose of 0.5-1/kg/day. The default is over 24 hours, but shorter intervals may be considered if a program of total parenteral nutrition cycling is recommended. Omegaven® will be infused intravenously through either a central or peripheral catheter.
Drug: Omegaven
Omegaven® fat emulsion will be used as a compassionate use treatment for critically ill infants with parenteral nutrition associated liver injury




Primary Outcome Measures :
  1. Number of Participant With Decrease in Direct Bilirubin Level [ Time Frame: First month of treatment ]
    Number of participant with decrease in direct bilirubin levels within 30 days of treatment


Secondary Outcome Measures :
  1. Number of Participant With Resolution of Direct Hyperbilirubinemia [ Time Frame: 2 months ]
    Number of participant with Direct bilirubin level of <2mg/dL at discontinuation of treatment

  2. Number of Participant With Preservation of Length [ Time Frame: Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment ]
    Monitoring of weekly length while the patient is receiving Omegaven® treatment

  3. Number of Participant With Preservation of Head Circumference [ Time Frame: Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment ]
    Monitoring of weekly head circumference while the patient is receiving Omegaven® treatment

  4. Number of Participant With Preservation of Normal Weight Gain [ Time Frame: Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment ]
    Monitoring of daily weight gain while the patient is on Omegaven®



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than 14 days old
  • Has parenteral nutrition associated cholestasis defined as at least 2 consecutive direct bilirubin >2 mg/dL with anatomical or functional short gut (OR >4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin > 0.4
  • Patient is parenteral nutrition dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require parenteral nutrition for at least 3 more weeks
  • Patient has not responded to other therapeutic approaches for parenteral nutrition-associated liver disease such as : cycling of parenteral nutrition, avoiding overfeeding, reduction/removal of copper and manganese from parenteral nutrition, advancement of enteral feeding, and use of Ursodiol
  • Patient has been on at least 2 weeks of SMOFLIPIDs with no improvement or worsening of direct bilirubin levels
  • Signed patient informed consent
  • The patient is expected to have a reasonable possibility of survival
  • No other known etiology of cholestasis other than parenteral nutrition-associated liver disease at the time of Omegaven® initiation

Exclusion Criteria:

  • Known causes of cholestasis other than parenteral nutrition-associated liver disease including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 antitrypsin deficiency are present, prior to Omegaven® initiation
  • Known fish or egg allergy
  • Any of the contraindications to use of Omegaven®:

    1. Active new infection at the time of initiation of Omegaven®
    2. Hemodynamic instability
    3. Recent use of medications with associated risk of bleeding, including NSAIDs
    4. Active coagulopathy or bleeding
    5. Platelet counts persistently under 30,000 despite transfusions
    6. Unstable hyperglycemia
    7. Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1 g/kg/day or less of Intralipid
    8. History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
    9. Unstable diabetes mellitus
    10. Collapse and shock
    11. Stroke/ Embolism
    12. Cardiac infarction within the last 3 months
    13. Undefined coma status

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): NCT03662282


Locations
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United States, Florida
USF Health
Tampa, Florida, United States, 33606
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Thao Ho, DO University of South Florida
  Study Documents (Full-Text)

Documents provided by University of South Florida:
Study Protocol  [PDF] May 1, 2018
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03662282    
Other Study ID Numbers: 00033519
First Posted: September 7, 2018    Key Record Dates
Results First Posted: July 22, 2020
Last Update Posted: July 22, 2020
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of South Florida:
Omegaven
parenteral nutrition
Liver disease
Cholestasis
Additional relevant MeSH terms:
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Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases