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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04807478
Other study ID # OMEG-038-CP4
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date May 1, 2029

Study information

Verified date August 2022
Source Fresenius Kabi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will demonstrate Short-, mid-, and long-term safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population


Description:

Prospective, controlled, longitudinal-cohort phase IV study to assess safety of Omegaven in Pediatric Patients with PNAC, in order to demonstrate short-, mid-, and long-term safety with respect to EFAD, serious bleeding events, life-threatening pleural and pericardial effusions, and neurocognitive development. Pediatric patients with PNAC receiving Omegaven as part of their routine nutritional management will be compared to those treated with another FDA-approved ILE for pediatric patients. Patients who are switched to a non-FDA-approved ILE or to Omegaven will be analyzed separately. Use of ILE will be as indicated by their treating physician, ideally for ≥ 1 year. Dosing modalities are to be taken from the pertinent prescribing information.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 1, 2029
Est. primary completion date May 1, 2028
Accepts healthy volunteers No
Gender All
Age group 1 Day and older
Eligibility Inclusion Criteria: 1. Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF). 2. Patient is PN-dependent and within the past 21 days has been diagnosed with PNAC, defined as direct or conjugated bilirubin (DBil) = 2.0 mg/dL with no other known cause of liver dysfunction at the time of enrollment. 3. Patient has feeding intolerance or at least one gastrointestinal disorder requiring PN. 4. Patient is < 6 months corrected age (expected time of delivery to time of screening). Exclusion Criteria: 1. Patient has any other known cause of chronic liver disease such as hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion due to heart failure, etc. 2. Patient has known cirrhosis (liver biopsy is not required under this protocol). 3. Patient has known portal vein thrombosis (imaging studies are not required under this protocol). 4. Patient has previously received a liver-only or liver-inclusive transplant. 5. Patient has a major cardiac anomaly with hemodynamic instability. 6. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer). 7. Patient has multi-organ failure, septic shock, hypotension requiring pressor therapy, persistent pulmonary hypertension requiring inhaled nitric oxides, or requires extracorporeal membrane oxygenation (ECMO) or similar intervention. 8. Patient has renal failure and requires dialysis. 9. Patient has a severe hemorrhagic disorder. 10. Patient has an INR > 2.0. 11. Patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level > 1,000 mg/dL). 12. Patient has a record of a previous T:T ratio = 0.2 or had a previous diagnosis of EFAD. 13. Patient has a central nervous system anomaly (e.g., anencephaly) or any injury (e.g., grade 3 or 4 intraventricular hemorrhage, moderate to severe hypoxic ischemic encephalopathy) that will affect neurodevelopment. 14. Patient has been diagnosed with or is suspected to have a genetic disorder known to be associated with neurodevelopmental impairment (e.g., trisomy 21, 18, 13). 15. Patient has been diagnosed with or is suspected to have an inborn error of metabolism. 16. Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven. 17. Patient's medical care has been deemed futile by the medical team. 18. Patient is enrolled in any other study with an investigational medicinal product.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Omegaven® (fish oil triglycerides) Injectable Emulsion
Dose, frequency and duration is a decision of the Investigator

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fresenius Kabi

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events (AEs)/serious adverse events (SAEs) The incidence of adverse events (AEs)/serious adverse events (SAEs) Through study completion, a maximum of 6 years
Primary Incidence of: Incidence of EFAD
Incidence of serious bleeding events
Incidence of life-threatening pericardial effusion events
Incidence of life-threatening pleural effusion events
Severity of any neurodevelopmental delays.
Through study completion, a maximum of 6 years
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