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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 17
Healthy Volunteers: f
View:
• Male or female patients, at least 1 month of age.
• Patients who require PN for at least 5 days/week.
• 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.
• 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).
Locations
United States
Georgia
Emory University Hospital
RECRUITING
Atlanta
Illinois
The University of Chicago
NOT_YET_RECRUITING
Chicago
Indiana
Riley Hospital for Children
RECRUITING
Indianapolis
Ohio
Nationwide Children's Hospital
NOT_YET_RECRUITING
Columbus
Pennsylvania
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
Contact Information
Primary
Martin Stumpf, PhD
martin.stumpf@fresenius-kabi.com
+49 6172 686
Backup
Jean-Marc Lohse, PhD
Jean-Marc.Lohse@fresenius-kabi.com
+49 6172 686
Time Frame
Start Date: 2024-10-28
Estimated Completion Date: 2026-09
Participants
Target number of participants: 100
Treatments
Other: Single arm SMOFlipid® (lipid injectable emulsion)
Investigational drug: SMOFlipid® (lipid injectable emulsion).
Related Therapeutic Areas
Sponsors
Leads: Fresenius Kabi