Total Parenteral Nutrition-Induced CholestasisNCT02328768
Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children
A study testing Omegaven in people with Total Parenteral Nutrition-Induced Cholestasis, run by University of Nebraska at 1 site in United States.
Trial summary
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated liver disease. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Total Parenteral Nutrition-Induced Cholestasis
- What is being tested?
- Omegaven
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parenteral nutrition (PN) dependent (unable to meet nutritional needs solely by enteral nutrition) and expected to require PN for at least another 30 days.
- Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin ≥ 2mg/dL or by histology and/or currently on Omegaven through another protocol.
- Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
- Exhaustion of standard therapies to prevent the progression of the liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese form PN, advancement of enteral feeding, and the use of ursodiol.
Who cannot join
- Pregnancy
- Other causes of liver disease
- Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent/guardian or subject is unwilling to provide consent and assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
About this study
Official title: Compassionate Use of an Intravenous Fish Oil Lipid Emulsion (Omegaven®) for the Treatment of Intestinal Failure Associated Liver Disease in Children
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated liver disease. It is a compassionate use protocol for patients who already have significant liver disease related to parenteral nutrition.
Read the detailed description
Parenteral Nutrition (PN) is a potentially life-saving intervention for children with short bowel syndrome and intestinal failure. Many common neonatal surgical diseases including Necrotizing enterocolitis (NEC), intestinal atresias, and gastroschisis can cause intestinal failure. The recovery from these illnesses often involves prolonged periods of parenteral nutrition. Intestinal Failure Associated Liver Disease (IFALD) is the most prevalent complication of long term parenteral nutrition in children, affecting up to 2/3 of children with short bowel syndrome. Parenteral lipids are an important source of calories in children, and provide essential fatty acids. Development of IFALD is a multifactorial process. Phytosterols contained in soybean based lipid emulsions have been shown to predispose animals to IFALD. Previous studies in children have shown that dosing the soybean based parenteral lipid emulsion at doses greater than 1g/kg/day may contribute to the development of IFALD. It is currently our practice to limit the lipid dose in children at risk of development of IFALD to 1g/kg/day. Despite this, some patients will still develop biochemical evidence of cholestasis and IFALD. Previous studies in humans have shown that children with IFALD who were administered the intravenous fish oil lipid emulsion Omegaven® reduced their serum direct bilirubin levels. This may be due to a reduction in the amount of arachidonic acide derived inflammatory mediators. The investigators hypothesize that administering Omegaven® in place of conventional soybean fat emulsions may reverse or prevent the progression of PN associated cholestasis and thus allow the patient to be maintained on adequate PN until he/she is able to ingest adequate nutrition enterally.
- Being tested
- Omegaven
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmegavenDrug
Also called Intravenous fish oil emulsion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Parenteral Nutrition-Induced CholestasisStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital and Medical Center, Omaha, Nebraska
- Responsible party
- Sponsor
- Investigators
- Brian A Jones, MD, Principal investigator, University of Nebraska Medical Center/Children's Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328768
- Sponsor's protocol ID
- 0018-15-FB
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2014
- Last updated
- 9 Jan 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use of an Intravenous Fish Oil Lipid Emulsion (Omegaven®) for the Treatment of Intestinal Failure Associated Liver Disease in Children
- ClinicalTrials.gov ID
- NCT02328768
- Acronym / sponsor ID
- 0018-15-FB
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Children's Hospital and Medical Center, Omaha, Nebraska
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this study is to determine if replacing standard soybean oil based fat emulsions with Omegaven®, a fish oil based fat emulsion, can reverse or prevent the progression of parenteral nutrition associated liver disease. It is a compassionate use protocol for patients who already have significant liver disease related to parenteral nutrition.
Detailed description
Parenteral Nutrition (PN) is a potentially life-saving intervention for children with short bowel syndrome and intestinal failure. Many common neonatal surgical diseases including Necrotizing enterocolitis (NEC), intestinal atresias, and gastroschisis can cause intestinal failure. The recovery from these illnesses often involves prolonged periods of parenteral nutrition. Intestinal Failure Associated Liver Disease (IFALD) is the most prevalent complication of long term parenteral nutrition in children, affecting up to 2/3 of children with short bowel syndrome. Parenteral lipids are an important source of calories in children, and provide essential fatty acids. Development of IFALD is a multifactorial process. Phytosterols contained in soybean based lipid emulsions have been shown to predispose animals to IFALD. Previous studies in children have shown that dosing the soybean based parenteral lipid emulsion at doses greater than 1g/kg/day may contribute to the development of IFALD. It is currently our practice to limit the lipid dose in children at risk of development of IFALD to 1g/kg/day. Despite this, some patients will still develop biochemical evidence of cholestasis and IFALD. Previous studies in humans have shown that children with IFALD who were administered the intravenous fish oil lipid emulsion Omegaven® reduced their serum direct bilirubin levels. This may be due to a reduction in the amount of arachidonic acide derived inflammatory mediators. The investigators hypothesize that administering Omegaven® in place of conventional soybean fat emulsions may reverse or prevent the progression of PN associated cholestasis and thus allow the patient to be maintained on adequate PN until he/she is able to ingest adequate nutrition enterally.
Study design
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Parenteral nutrition (PN) dependent (unable to meet nutritional needs solely by enteral nutrition) and expected to require PN for at least another 30 days.
- Parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin ≥ 2mg/dL or by histology and/or currently on Omegaven through another protocol.
- Other causes of liver disease have been excluded. A liver biopsy is not necessary for treatment.
- Exhaustion of standard therapies to prevent the progression of the liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese form PN, advancement of enteral feeding, and the use of ursodiol.
Key exclusion criteria (4 listed)
- Pregnancy
- Other causes of liver disease
- Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
- The parent/guardian or subject is unwilling to provide consent and assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OmegavenAlso: Intravenous fish oil emulsion | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian A Jones, MD principal investigator
University of Nebraska Medical Center/Children's Hospital & Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omegaven in people with Total Parenteral Nutrition-Induced Cholestasis, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.