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NCT06274788 · ClinicalTrials.gov registry record
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
A clinical trial of Pediatric ALL and Malnutrition, sponsored by Fresenius Kabi.
- Recruiting
- Registry status
- 40
- Enrollment target
- 10
- Study locations
NCT06274788: Recruiting study of Pediatric ALL and Malnutrition, sponsored by Fresenius Kabi.
NCT06274788 is a study of Pediatric ALL and Malnutrition that is actively recruiting participants, run by Fresenius Kabi. The registered enrollment target is 40 participants, below the 1,646-participant average among 21 other Pediatric ALL trials with a reported enrollment target (98% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06274788, a study of Pediatric ALL and Malnutrition, is actively recruiting participants, sponsored by Fresenius Kabi.
- RECRUITING
- Registry status
- 40 participants
- Enrollment target
- 10
- Study locations
Study 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
Primary Outcome
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)
Conditions Studied
Interventions
- DRUG Omegaven® (fish oil triglycerides) Injectable Emulsion
Study Locations (10)
California
- Memorial Health Service - Fountain Valley
- University of California Los Angeles - Los Angeles
Texas
- Baylor College of Medicine Houston - Houston
- The University of Texas Health Science Center at San Antonio - San Antonio
Illinois
- The University of Chicago - Chicago
Massachusetts
- Children's Hospital Corporation d/b/a Boston Children's Hospital - Boston
Ohio
- Children's Hospital Medical Center - Cincinnati
Oklahoma
- Board of Regents of the University of Oklahoma Health Sciences Center - Oklahoma City
Tennessee
- Vanderbilt University Medical Center - Nashville
Washington
- Seattle Children's Hospital d/b/a Seattle Children's Research Institute - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-12-15 |
| Est. Completion | 2027-03-01 |
What NCT06274788 shows while recruiting
NCT06274788 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,646-participant average among 21 other Pediatric ALL trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Pediatric ALL appearing as the primary indexed condition, and to 1 intervention - of which Omegaven® (fish oil triglycerides) Injectable Emulsion is the first listed.
NCT06274788 lists 10 locations in 8 states (California, Texas, Illinois).
Frequently Asked Questions
What is clinical trial NCT06274788 about?
NCT06274788 is a clinical study titled "Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment". 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
What is the current status of trial NCT06274788?
This trial is currently recruiting. The enrollment target is 40 participants. The study started on 2024-12-15. Estimated completion is 2027-03-01.
What conditions does trial NCT06274788 study?
This clinical trial studies the following conditions: Pediatric ALL, Malnutrition, Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency.
What interventions are being tested in trial NCT06274788?
The interventions under investigation include: Omegaven® (fish oil triglycerides) Injectable Emulsion (DRUG).
Who is sponsoring clinical trial NCT06274788?
This trial is sponsored by Fresenius Kabi, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06274788 being conducted?
This trial has 10 study locations across California, Illinois, Massachusetts, Ohio, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06274788's enrollment target sits among peer trials
40 14th of 21 higher than 7 of 21 other Pediatric ALL trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pediatric ALL trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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