Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver D… (NCT01297933) | Clinical Trial Compass
APPROVED_FOR_MARKETINGNot Applicable
Compassionate Use of Omegaven for Pediatric Patients With Parenteral Nutrition Associated Liver Disease
United States
Plain-language summary
A compassionate use protocol to provide Omegaven to pediatric patients with parenteral nutrition (PN) dependence and parenteral nutrition associated liver disease (PNALD).
Who can participate
Age range
21 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:
* PN dependence due to congenital or acquired gastrointestinal disease
* Predicted PN requirement for at least an additional 30 days
* Parenteral nutrition associated liver disease (PNALD), defined as two conjugated bilirubin levels \>= 2 mg/dL at least one week apart, must be obtained to demonstrate persistence of PNALD
* Failure to respond to standard therapies which may include cycling PN, reduction in the dose of soybean derived IFE, attempts to advance enteral feeds, ursodiol, metronidazole, and avoidance of excessive caloric provision
* signed parent or legal guardian informed consent
Exclusion Criteria:
* Acute treatable infection (e.g. urinary tract infection, sepsis)
* Known allergy to egg or fish protein
* Contraindications to Omegaven
* Pregnancy
* Serum triglyceride level greater than 400 mg/dL at baseline
* History of severe hemolytic disorders or INR greater than 1.5 at baseline (INR cutoff of greater than 2 for infants less than 1 week of age)
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.