NCT06049680 Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients
| NCT ID | NCT06049680 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fresenius Kabi |
| Condition | Malnutrition, Child |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2024-10-28 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate the risk of developing EFAD and/or PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.
Eligibility Criteria
Age Limits: and Adults Inclusion Criteria: 1. Male or female patients, at least 1 month of age. 2. Patients who require PN for at least 5 days/week. 3. Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total energy requirements as PN for at least 56 days. 4. Written informed consent. In case of pediatric patients, informed consent must be obtained from parent(s) or legal representatives. If possible, the assent of the pediatric patient must also be obtained (according to local law). Exclusion Criteria: 1. Use of any other lipid injectable emulsion than SMOFlipid within 6 months prior to study participation 2. Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of SMOFlipid. 3. Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \>250 mg/dL in infants or \>400 mg/dL in older pediatric and adult patients). 4. Inborn errors of amino acid metabolism. 5. Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support). 6. Hemophagocytic syndrome. 7. Liver enzymes (either AST, or ALT, or GGT) exceeding 2 x upper limit of normal range 8. Direct bilirubin exceeding 2 x upper limit of normal range 9. INR exceeding 2 x upper limit of normal range and patient not receiving oral anticoagulants. 10. Any known hepatic condition outside of IFALD that will increase direct bilirubin ≥2.0 mg/dL. 11. Clinically significant abnormal levels of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate). 12. Active bloodstream infection demonstrated by positive blood culture at screening. 13. Severe renal failure (eGFR \<15 ml/min per 1.73 m2) including patients on renal replacement therapy. 14. Abnormal blood pH, oxygen saturation, or carbon dioxide. 15. Pregnancy or lactation. 16. Participation in another interventional clinical study. 17. Unlikely to survive longer than 56 days.
Contact & Investigator
Jeffrey Rudolph, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06049680 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 17 Years, studying Malnutrition, Child. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06049680 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06049680 currently recruiting?
Yes, NCT06049680 is actively recruiting participants. Contact the research team at martin.stumpf@fresenius-kabi.com for enrollment information.
Where is the NCT06049680 trial being conducted?
This trial is being conducted at Atlanta, United States, Chicago, United States, Indianapolis, United States, Columbus, United States and 1 additional location.
Who is sponsoring the NCT06049680 clinical trial?
NCT06049680 is sponsored by Fresenius Kabi. The principal investigator is Jeffrey Rudolph, MD at University of Pittsburgh. The trial plans to enroll 100 participants.