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RECRUITING

Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment

NCT06274788 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 40 participants
Start Date 2024-12-15
Est. Completion 2027-03-01

Sponsor

Fresenius Kabi

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06274788

The ClinicalTrials.gov registry entry for NCT06274788 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fresenius Kabi, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06274788 reports 10 study locations spanning 8 distinct geographic areas — top geographies include California, Texas, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06274788?

The interventions under investigation include: Omegaven® (fish oil triglycerides) Injectable Emulsion (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06274788?

This trial is sponsored by Fresenius Kabi, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial