Trial record 13 of 144 for:    Open Studies | "Bile Duct Diseases"

Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants

This study is currently recruiting participants.
Verified May 2013 by Baylor College of Medicine
Sponsor:
Collaborator:
Children's Hospital Boston
Information provided by (Responsible Party):
Steve Abrams, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00738101
First received: August 18, 2008
Last updated: May 17, 2013
Last verified: May 2013
  Purpose

To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.


Condition Intervention
Cholestasis
Parenteral Nutrition
Drug: Omegaven

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Compassionate Use of an Intravenous Fat Emulsion Comprised of Fish Oil in the Treatment of Parenteral Nutrition Induced Liver Injury in Infants

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Safety analysis will include all subjects who receive at least one dose of study drug [ Time Frame: Maximum 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: September 2008
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Omegaven
Drug: Omegaven
Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 5 years. If the infant no longer is requiring any TPN, then the Omegaven will be stopped regardless of bilirubin. If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.
Other Name: Omega-3 enriched fat emulsion

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be greater than 14 days old and less than 5 years old
  • Critically ill infants with either a known anatomic short gut (greater than 50% of the bowel removed) or known severe dysmotility of the gut reflecting non-functional gut similar to anatomic short gut will be offered Omegaven® when their direct bilirubin reaches 2 mg/dL. Infants who do not meet the above criteria for anatomic or dysfunctional short gut will be allowed to receive Omegaven® when their direct bilirubin reaches 4 mg/dL
  • Be receiving at least 60% of their calories by intravenous infusion
  • Be expected to require intravenous nutrition for at least an additional 28 days

Exclusion Criteria:

  • Have a congenitally lethal condition (e.g. Trisomy 13).
  • Have clinically severe bleeding not able to be managed with routine measures.
  • Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
  • Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.

Home Use of Omegaven®:

In order for a subject to receive the Omegaven® at home through a home health care agency, subjects will first be required to be admitted to Texas Children's Hospital for 72 hours in initiate the administration of the Omegaven®. This will allow time for observation of any unexpected side effects and for parents to be provided education on home TPN and Omegaven®.

If a subject has already received Omegaven® either at TCH or at another hospital, they will not be required to be admitted for the 72 hour inpatient admission prior to starting Omegaven® at home. Parent training will occur during the previous hospital admission and will continue through the TCH Pediatric Intestinal Rehabilitation Clinic.

Outpatient Monitoring:

After the initial evaluation by the TCH Pediatric Intestinal Rehabilitation Clinic physicians, subjects will return to the clinic for routine follow-up. Subjects will be asked to return to the clinic every 2 weeks for the first 2 months of treatment. Thereafter, subjects will return to the clinic on a monthly basis, or as directed by the clinic team.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738101

Contacts
Contact: Steve A Abrams, MD 713-798-7124 sabrams@bcm.edu
Contact: Keli M Hawthorne, MS, RD 713-798-7085 kelih@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Keli M Hawthorne, MS, RD    713-798-7085    kelih@bcm.edu   
Sub-Investigator: Beth A Carter, MD         
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Keli M Hawthorne, MS, RD    713-798-7085    kelih@bcm.edu   
Sub-Investigator: Beth A Carter, MD         
Sponsors and Collaborators
Baylor College of Medicine
Children's Hospital Boston
Investigators
Principal Investigator: Steve A Abrams, MD Baylor College of Medicine
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steve Abrams, MD, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00738101     History of Changes
Other Study ID Numbers: H-23365
Study First Received: August 18, 2008
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor College of Medicine:
Omega-3
Omegaven
Cholestasis
Liver damage

Additional relevant MeSH terms:
Cholestasis
Wounds and Injuries
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 20, 2014