Trial record 14 of 30 for:    Open Studies | "Malabsorption Syndromes" | United States

Compassionate Use of Omegaven in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by University of Oklahoma
Sponsor:
Collaborator:
OU Medical Center
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT02370251
First received: February 17, 2015
Last updated: November 17, 2015
Last verified: November 2015
  Purpose
This is a single-assignment study to evaluate whether Omegaven (IV fish oil) is effective at treating liver disease in children on long-term IV nutrition.

Condition Intervention Phase
Total Parenteral Nutrition-induced Cholestasis
Cholestasis
Short Bowel Syndrome
Gastroschisis
Intestinal Atresia
Infant, Premature, Diseases
Cholestasis of Parenteral Nutrition
Drug: Omegaven
Drug: Omegaven + Intralipid
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fish Oil Lipid Emulsion for the Treatment of Parenteral-Nutrition-Associated Liver Disease in Infants

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Resolution of cholestasis [ Time Frame: Within the first 3 months of sole Omegaven use ] [ Designated as safety issue: No ]
    To determine if Omegaven results in the resolution of cholestasis (DB <2 for 2 consecutive weeks)


Secondary Outcome Measures:
  • Safety issues [ Time Frame: Within the first year of use ] [ Designated as safety issue: Yes ]
    To determine if Omegaven results in safety issues such as increased bleeding, essential fatty acid deficiency, elevated triglyceride levels, elevated liver function tests, increased liver and/or intestinal transplant rates, or death

  • Essential fatty acid deficiency [ Time Frame: Within the first three months of combined use ] [ Designated as safety issue: No ]
    To determine if the combination of Omegaven and Intralipid results in normalized lipid profiles.


Estimated Enrollment: 200
Study Start Date: June 2015
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omegaven
Children will receive Omegaven at a maximum of 1 g/kg/day upon enrollment in this arm.
Drug: Omegaven
Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs.
Other Names:
  • Fish oil-based lipid
  • Omega-3-fatty acid lipid emulsion
Experimental: Omegaven + Intralipid
Once a child's direct bilirubin level has normalized, soybean emulsion (Intralipid) may be reintroduced at 0.5-1 g/kg/day 3 times a week.
Drug: Omegaven
Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs.
Other Names:
  • Fish oil-based lipid
  • Omega-3-fatty acid lipid emulsion
Drug: Omegaven + Intralipid
Infants who experience resolution of cholestasis and continue to require IV lipids will have Intralipid added back at a dose of 0.5 g/kg/day (if enteral intake is 50-99 ml/kg/day) or 1 g/kg/day (if enteral intake is 0-49 ml/kg/day) three times weekly. Essential fatty acid profiles will be monitored.
Other Names:
  • Fish oil-based lipid + Soybean oil-based lipid
  • Omega-3-fatty acid lipids + Omega-6-fatty acid lipids

Detailed Description:

Children up to 18 years of age, on parenteral nutrition, with a direct bilirubin level of 2 mg/dL or greater will be eligible to receive Omegaven at a maximum dose of 1 g/kg/day.

Up to 200 children will be eligible for enrollment.

Direct bilirubin levels and other labs will be monitored as well as growth parameters.

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Live in or temporarily relocate to Oklahoma
  • Age less than 18 years, both sexes, all races
  • Have a direct bilirubin level of ≥2 mg/dL for two consecutive weeks after at least 14 days of parenteral nutrition
  • Received parenteral lipids at a maximum dose of 1.5 g/kg/day (21 g/kg over the two weeks prior)
  • Are not currently enrolled in another lipid emulsion study

Exclusion Criteria:

  • Known food allergy to fish
  • Known metabolic disorder of lipid metabolism
  • Active coagulopathies (active bleeding or requiring blood product treatment in the prior 48 hours)
  • Medical condition likely to result in death in the next 30 days
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02370251

Contacts
Contact: Kimberly D Ernst, MD, MSMI 405-271-5215 ext 42039 omegaven@ouhsc.edu
Contact: Susan Bedwell, APRN 405-271-6169 susan.bedwell@hcahealthcare.com

Locations
United States, Oklahoma
OU Children's Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kimberly D Ernst, MD    405-271-5266    omegaven@ouhsc.edu   
Contact: Kimberly M Benjamin, RN    405-271-5215 ext 43006    kimberly-benjamin@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
OU Medical Center
Investigators
Principal Investigator: Kimberly D Ernst, MD, MSMI The University of Oklahoma, Department of Pediatrics
  More Information

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT02370251     History of Changes
Other Study ID Numbers: 5451 
Study First Received: February 17, 2015
Last Updated: November 17, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Fat Emulsions, Intravenous
Parenteral-Nutrition-Associated Liver Disease
Cholestasis
Omegaven
Fish Oil

Additional relevant MeSH terms:
Malabsorption Syndromes
Cholestasis
Short Bowel Syndrome
Gastroschisis
Infant, Premature, Diseases
Intestinal Atresia
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Postoperative Complications
Pathologic Processes
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Digestive System Abnormalities
Soybean oil, phospholipid emulsion
Bilirubin
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2016