Total Parenteral Nutrition-induced CholestasisNCT02929303
Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
A study testing Omegaven IV lipid emulsion in people with Total Parenteral Nutrition-induced Cholestasis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Total Parenteral Nutrition-induced Cholestasis
- What is being tested?
- Omegaven IV lipid emulsion
- 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 17 years
- All sexes
- Child
Who may be able to join
- Pediatric patients aged 0 - 18 yrs
- Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition). It will be assumed that patients will require parenteral nutrition for at least 30 days from the inclusion into the study.
- Patients must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
- 2 consecutive direct bilirubins > 2.0 mg/dl. one week apart.
- Signed patient informed consent.
- The patient must have utilized standard therapies as clinically appropriate to prevent the progression of his/her liver disease. Such therapies could include surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i.e.,Actigall).
Who cannot join
- Documented cause of chronic liver disease other than parenteral nutrition associated liver disease.
- An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven.
- Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis.
- Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis.(e.g. (triglycerides > 1000mg/dl while receiving intralipid 1g/kg/day or less)
- Unstable diabetes mellitus or hyperglycemia (Blood glucose >200 mg/dL) at the time of initiation of Omegaven
- Currently being treated for stroke, embolism, collapse and shock, myocardial infarction.
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- Cholestasis due to any reason other than parenteral associated liver disease
- Active new infection at time of initiation of Omegaven
- Hemodynamic instability (e.g. receiving vasopressors) at time of initiation of Omegaven.
- The patient may not be enrolled in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team).
- Known pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Children's Hospital
Park Ridge, Illinois, 60068
About this study
Official title: Expanded Access of Omegaven IV Fat Emulsion (Fish Oil Infusion) to Infants and Children With Parenteral Nutrition-associated Liver Disease
This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin.
This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.
Read the detailed description
The etiology of parenteral nutrition associated liver disease (PNALD) is currently considered multifactorial. Available treatment options for this disease process are limited and have achieved moderate success at best. Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. The investigators hypothesize that administering Omegaven™ to patients with PNALD in place of conventional fat emulsion may reverse cholestasis allowing patients to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.
- Being tested
- Omegaven IV lipid emulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omegaven IV lipid emulsionDrug
Therapy is started at a dose of 1 gm/kg/day over 12 hrs. Omegaven may be infused via a central or peripheral IV. If additional fat calories are needed they will be provided by the enteral route.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Total Parenteral Nutrition-induced CholestasisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hector Hernandez, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929303
- Sponsor's protocol ID
- K5900315
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2016
- Last updated
- 28 Sep 2026
- Results posted
- No
Publications
Sant'Anna AM, Altamimi E, Clause RF, Saab J, Mileski H, Cameron B, Fitzgerald P, Sant'Anna GM. Implementation of a multidisciplinary team approach and fish oil emulsion administration in the management of infants with short bowel syndrome and parenteral nutrition-associated liver disease. Can J Gastroenterol. 2012 May;26(5):277-80. doi: 10.1155/2012/571829.
PubMed 22590701Soden JS, Lovell MA, Brown K, Partrick DA, Sokol RJ. Failure of resolution of portal fibrosis during omega-3 fatty acid lipid emulsion therapy in two patients with irreversible intestinal failure. J Pediatr. 2010 Feb;156(2):327-31. doi: 10.1016/j.jpeds.2009.08.033.
PubMed 20105644
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access of Omegaven IV Fat Emulsion (Fish Oil Infusion) to Infants and Children With Parenteral Nutrition-associated Liver Disease
- ClinicalTrials.gov ID
- NCT02929303
- Acronym / sponsor ID
- K5900315
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- First posted
- 11 Oct 2016 (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.
This is an expanded access protocol for use of intravenous fish oil infusion, Omegaven, in infants and children with parenteral nutrition associated liver disease (PNALD) to decrease elevated liver enzymes and direct bilirubin.
This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.
Detailed description
The etiology of parenteral nutrition associated liver disease (PNALD) is currently considered multifactorial. Available treatment options for this disease process are limited and have achieved moderate success at best. Unlike conventional intravenous fat emulsions, Omegaven™ is comprised solely of fish oils containing primarily omega-3 fatty acids. The investigators hypothesize that administering Omegaven™ to patients with PNALD in place of conventional fat emulsion may reverse cholestasis allowing patients to be maintained on adequate PN until they are able to ingest adequate nutrition enterally.
Study design
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (6 listed)
- Pediatric patients aged 0 - 18 yrs
- Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition). It will be assumed that patients will require parenteral nutrition for at least 30 days from the inclusion into the study.
- Patients must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of 2mg/dl or more. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
- 2 consecutive direct bilirubins > 2.0 mg/dl. one week apart.
- Signed patient informed consent.
Key exclusion criteria (11 listed)
- Documented cause of chronic liver disease other than parenteral nutrition associated liver disease.
- An allergy to any seafood product, egg protein, and/or previous allergy to Omegaven.
- Active coagulopathy characterized by ongoing bleeding or by a requirement for clotting factor replacement (e.g. fresh frozen plasma or cryoprecipitate) to maintain homeostasis.
- Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis.(e.g. (triglycerides > 1000mg/dl while receiving intralipid 1g/kg/day or less)
- Unstable diabetes mellitus or hyperglycemia (Blood glucose >200 mg/dL) at the time of initiation of Omegaven
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 |
|---|---|---|
| Omegaven IV lipid emulsionTherapy is started at a dose of 1 gm/kg/day over 12 hrs. Omegaven may be infused via a central or peripheral IV. If additional fat calories are needed they will be provided by the enteral route. | 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 28 Sep 2026.
- Results publication: PubMed 22590701Sant'Anna AM, Altamimi E, Clause RF, Saab J, Mileski H, Cameron B, Fitzgerald P, Sant'Anna GM. Implementation of a multidisciplinary team approach and fish oil emulsion administration in the management of infants with short bowel syndrome and parenteral nutrition-associated liver disease. Can J Gastroenterol. 2012 May;26(5):277-80. doi: 10.1155/2012/571829.
- Results publication: PubMed 20105644Soden JS, Lovell MA, Brown K, Partrick DA, Sokol RJ. Failure of resolution of portal fibrosis during omega-3 fatty acid lipid emulsion therapy in two patients with irreversible intestinal failure. J Pediatr. 2010 Feb;156(2):327-31. doi: 10.1016/j.jpeds.2009.08.033.
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.
Hector Hernandez, MD principal investigator
Wake Forest University Health Sciences
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 IV lipid emulsion in people with Total Parenteral Nutrition-induced Cholestasis, run by Wake Forest University Health Sciences 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 6 inclusion and 11 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 28 Sep 2026. 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?
On the ClinicalTrials.gov record for NCT02929303, which also lists 2 linked publications.
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 28 Sep 2026.