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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06274788
Other study ID # OMEG-054-CP4
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date May 1, 2024
Est. completion date March 1, 2027

Study information

Verified date March 2024
Source Fresenius Kabi
Contact Schneider-Schranz Cornelia, PhD
Phone +491737335940
Email cornelia.schneider-schranz@fresenius-kabi.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will demonstrate 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date March 1, 2027
Est. primary completion date March 1, 2026
Accepts healthy volunteers No
Gender All
Age group 1 Day to 17 Years
Eligibility Inclusion Criteria: 1. Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF). 2. Pediatric patient (<18 years) 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 and is expected to require Omegaven treatment for at least eight weeks. 3. Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN. Exclusion Criteria: 1. Patient has received Omegaven within four weeks before inclusion in the study 2. 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. 3. Patient has known cirrhosis (liver biopsy is not required under this protocol). 4. Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis. 5. Patient has previously received a liver-only or liver-inclusive transplant. 6. Patient has hemodynamic instability due to any major cardiac anomaly. 7. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer). 8. 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. 9. Patient has renal failure and requires renal replacement therapy. 10. Patient has a severe hemorrhagic disorder. 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 EFAD before inclusion in the study 13. Patient has been diagnosed with or is suspected to have an inborn error of metabolism. 14. Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven. 15. Patient is subject to treatment limitation. 16. Patient is enrolled in any other study with an investigational medicinal product during the course of the current study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Omegaven® (fish oil triglycerides) Injectable Emulsion
Pediatric patients Pediatric patients with new-onset PNAC 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
Primary Incidence of essential fatty acid deficiency (EFAD) EFAD as defined by the triene:tetraene (T:T) ratio; severity of EFAD will be graded and analysed based on T:T ratio (suspected = 0.05, moderate = 0.20, and severe = 0.40) Up to week 56
Secondary Incidence of clinical EFAD Clinical EFAD is defined by clinical symptoms (like dry, scaly rash, hair loss, hair depigmentation, poor wound healing, growth restriction, and increased susceptibility to infection) and T:T ratio = 0.083 Up to week 56
Secondary Time from treatment start to EFAD diagnosis Time from treatment start to EFAD diagnosis Up to week 56
Secondary Incidence of adverse events (AEs)/serious adverse events (SAEs) The incidence of AEs/SAEs considered by the Investigator to be related to study treatment Up to week 56
Secondary Routine laboratory tests: Direct or conjugated bilirubin Up to week 56
Secondary Routine laboratory tests: triglycerides Up to week 56
Secondary Fatty acid profiles: a-linolenic acid Up to week 56
Secondary Fatty acid profiles: linoleic acid Up to week 56
Secondary Fatty acid profiles: arachidonic acid Up to week 56
Secondary Fatty acid profiles: mead acid Up to week 56
Secondary Fatty acid profiles: oleic acid Up to week 56
Secondary Fatty acid profiles: docosahexaenoic acid (DHA) Up to week 56
Secondary Fatty acid profiles: eicosapentaenoic acid (EPA) Up to week 56
Secondary Anthropometric measures: body weight Up to week 56
Secondary Anthropometric measures: body height/length Up to week 56
Secondary Anthropometric measures: head circumference Up to week 56
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