- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01173159
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
June 8, 2020 updated by: Children's Hospital Medical Center, Cincinnati
Compassionate Use of a Fish Oil-derived Intravenous Fat Emulsion (Omegaven) to Reverse Parenteral Nutrition (PN) Induced Cholestasis
The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion containing fish oil) instead of the current lipid emulsion, which contains fat derived from soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better.
It may reduce the harmful effects to the liver, may stop any further liver damage and may reverse damage already done to the liver because of the prolonged use of nutrition through your child's IV.
Study Overview
Detailed Description
Enrollment of subjects into this study will occur for up to 4 years.
Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total parenteral nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females ages one month of age to 18 years of age
- Patients with intestinal failure on TPN
- Patients who have a conjugated/direct bilirubin of ≥3 mg/dl for more than weeks and in whom other causes of cholestasis have been excluded with reasonable certainty utilizing biochemical, serologic, microbiologic, and radiographic techniques. Liver biopsy is not required to rule out other disorders, but may be utilized at the clinician's discretion
- Patients in whom reduction of IV soy-based lipid to an average <1.2g/kg body weight/day has failed to reduce the conjugated/direct bilirubin within ≥ 30 days of implementation
- Willing to use birth control during study participation for females of child- bearing potential, as determined by investigator.
- Signed informed consent for use of Omegaven® obtained
Exclusion Criteria:
Any of the contraindications to use of Omegaven®
Impaired lipid metabolism (triglycerides >1000 mg/dL) while on
1g/kg/day or less of Intralipid
- History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
- Unstable diabetes mellitus
- Collapse and shock
- Stroke/ Embolism
- Cardiac infarction within the last 3 months
- Undefined coma status
- Pregnancy (positive pregnancy test) prior to enrollment in the study for females of child-bearing potential
- Females of child-bearing potential who are unwilling to use birth control during study participation
- Parental decision to forego the use of Omegaven®
- Known fish or egg allergy
- Pregnancy
- Causes of liver disease other than Parenteral Nutrition Associated Cholestasis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Omegaven
Subjects will receive Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require Total Parenteral Nutrition or until their conjugated/direct bilirubin has normalized and their enteral lipid intake is sufficient to discontinue intravenous lipids.
|
For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours).
Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature.
Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids.
Omegaven® is isotonic.
It is compatible with parenteral nutrition solutions and may be co-infused via y-site.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Change in Conjugated/Direct Bilirubin
Time Frame: Completion of Therapy (time frame from 1-14 weeks)
|
Change in conjugated/direct bilirubin level to below 1 mg/dl.
|
Completion of Therapy (time frame from 1-14 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Change in Unconjugated/Total Bilirubin
Time Frame: Completion of Therapy (time frame from 1-14 weeks)
|
Change in unconjugated/total bilirubin level to below 1.1 mg/dL.
General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
|
Completion of Therapy (time frame from 1-14 weeks)
|
Number of Participants With a Change in Aspartate Transaminase (AST)
Time Frame: Completion of Therapy (time frame from 1-14 weeks)
|
Change in aspartate transaminase (AST) 57 units/L.
General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
|
Completion of Therapy (time frame from 1-14 weeks)
|
Number of Participants With a Change in Liver Enzyme (ALT)
Time Frame: Completion of Therapy (time frame from 1-14 weeks)
|
Change in liver enzyme ALT to below 59 unit/L.
General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
|
Completion of Therapy (time frame from 1-14 weeks)
|
Number of Participants With a Change in Liver Enzyme Alkaline Phosphatase
Time Frame: Completion of Therapy (time frame from 1-14 weeks)
|
Change in liver enzyme alkaline phosphatase to below 345 unit/L.
General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
|
Completion of Therapy (time frame from 1-14 weeks)
|
Number of Participants With a Change in Liver Enzyme Gamma-glutamyltransferase (GGT)
Time Frame: Completion of Therapy (time frame from 1-14 weeks)
|
Change in Liver Enzyme Gamma-glutamyltransferase (GGT) to below 15 unit/L.
General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
|
Completion of Therapy (time frame from 1-14 weeks)
|
Number of Participants With a Change in Triglycerides
Time Frame: Completion of Therapy (time frame from 1-14 weeks)
|
Change in Triglycerides to below 119 mg/dL.
General outcomes of participants are reported due to the enrollment of very few patients so that we have too small a cohort with which to assess achievement of our stipulated outcomes.
|
Completion of Therapy (time frame from 1-14 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Samuel Kocoshis, MD, Children's Hospital Medical Center, Cincinnati
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
July 29, 2010
First Submitted That Met QC Criteria
July 29, 2010
First Posted (Estimate)
July 30, 2010
Study Record Updates
Last Update Posted (Actual)
June 17, 2020
Last Update Submitted That Met QC Criteria
June 8, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-2314
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cholestasis
-
Institute of Liver and Biliary Sciences, IndiaKEM Hospital Research Centre; Apollo Hospital, New Delhi, India; Jaslok Hospital... and other collaboratorsRecruitingProgressive Familial Intrahepatic CholestasisIndia
-
University Medical Center GroningenEnrolling by invitationProgressive Familial Intrahepatic CholestasisNetherlands
-
Mirum Pharmaceuticals, Inc.CompletedProgressive Familial Intrahepatic Cholestasis (PFIC)Italy, United States, Argentina, France, Singapore, United Kingdom, Austria, Brazil, Mexico, Lebanon, Germany, Turkey, Poland, Belgium, Canada, Colombia, Hungary
-
TakedaActive, not recruitingProgressive Familial Intrahepatic Cholestasis (PFIC)Japan
-
Mirum Pharmaceuticals, Inc.Active, not recruitingProgressive Familial Intrahepatic Cholestasis (PFIC)United States, Argentina, France, Singapore, United Kingdom, Belgium, Turkey, Austria, Brazil, Canada, Colombia, Germany, Italy, Lebanon, Mexico, Poland
-
Mirum Pharmaceuticals, Inc.WithdrawnProgressive Familial Intrahepatic Cholestasis (PFIC)
-
AlbireoActive, not recruitingProgressive Familial Intrahepatic CholestasisUnited States, Spain, Netherlands, United Kingdom, Turkey, Canada, Italy, Germany, France, Israel, Australia, Belgium, Poland, Saudi Arabia, Sweden
-
Assiut UniversityCompletedExtrahepatic Cholestasis
-
Turku University HospitalCompletedPregnancy | Intrahepatic CholestasisFinland
-
Sisli Hamidiye Etfal Training and Research HospitalUnknown
Clinical Trials on Omegaven
-
Children's & Women's Health Centre of British ColumbiaChild and Family Research InstituteUnknownCholestasis | Parenteral Nutrition Associated Liver Disease (PNALD)Canada
-
National Taiwan University HospitalUnknownCritical Ill Patients in SICUTaiwan
-
Midwestern Regional Medical CenterTerminatedCancer | Hepatic InjuryUnited States
-
Jagiellonian UniversityCompletedGastrointestinal SurgeryPoland
-
Li Shin HospitalCompleted
-
Mark PuderCompletedGastrointestinal Disease | Short Bowel Syndrome | Parenteral Nutrition Associated Liver DiseaseUnited States
-
General University Hospital, PragueCharles University, Czech Republic; Ministry of Health, Czech RepublicCompletedParenteral NutritionCzechia
-
DHR Health Institute for Research and DevelopmentApproved for marketingParenteral Nutrition Associated Liver Disease
-
Rush University Medical CenterApproved for marketingCholestasis | Total Parenteral Nutrition-induced CholestasisUnited States