Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD (NCT02929303) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD
United States
Plain-language 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.
This study aims to describe the response of PNALD after use of Omegaven by normalization of serum levels of liver enzymes and bilirubin.
Who can participate
Age range
17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. Cholestasis due to any reason other than parenteral associated liver disease
. Active new infection at time of initiation of Omegaven