RECRUITING

Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD And/or PNAC in Pediatric and Adult Patients

Conditions

Malnutrition, Child Malnutrition Essential Fatty Acid Deficiency (EFAD)Parenteral Nutrition Associated Cholestasis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Single-arm Open-label Safety Study of SMOFlipid to Evaluate the Risk of Developing Essential Fatty Acid Deficiency (EFAD) And/or Parenteral Nutrition-associated Cholestasis (PNAC) in Pediatric Patients 1 Month to 17 Years of Age and in Adult Patients, Who Are Anticipated to Need 8 Weeks or Longer of Parenteral Nutrition Treatment

Quick Facts

Study Start:2024-10-28

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06049680

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Month to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Martin Stumpf, PhD

CONTACT

+49 6172 686

martin.stumpf@fresenius-kabi.com

Jean-Marc Lohse, PhD

CONTACT

+49 6172 686

Jean-Marc.Lohse@fresenius-kabi.com

Principal Investigator

Jeffrey Rudolph, MD

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Study Locations (Sites)

Riley Hospital for Children

Indianapolis, Indiana, 46202

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

United States

Collaborators and Investigators

Sponsor: Fresenius Kabi

Jeffrey Rudolph, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-28

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-10-28

Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

Malnutrition, Child
Malnutrition
Essential Fatty Acid Deficiency (EFAD)
Parenteral Nutrition Associated Cholestasis