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

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Fresenius Kabi
Study ID
NCT06274788
Status
Recruiting
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Conditions

  • Essential Fatty Acid Deficiency
  • Malnutrition
  • Parenteral Nutrition Associated Liver Disease (PNALD)
  • Pediatric ALL

Eligibility Criteria

Sex
ALL
Age
1 Day - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Omegaven® (fish oil triglycerides) Injectable Emulsion — DRUG
    Pediatric patients Pediatric patients with new-onset PNAC Drug: Omegaven® (fish oil triglycerides) Injectable Emulsion Dose, frequency and duration is a decision of the Investigator

Study Details

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

Key Dates

Start date
Dec 15, 2024
Status verified
Feb 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Single arm OMEGAVEN® (fish oil triglycerides; injectable emulsion)
    The dose of investigational drug (study treatment), as well as all other components of the overall nutritional regimen is solely at the discretion of the Investigator. It is assumed the Investigator will use sound medical judgement, follow institutional standards of care regarding the nutrition provided to each patient, and review applicable prescribing information indicating the maximum and recommended dose of Omegaven of 1 g/kg/day infused intravenously over 8 to 24 hours as long as the infusion rate does not exceed 1.5 mL/kg/hour.

Primary Outcome Measure

Incidence of essential fatty acid deficiency (EFAD) [ Time Frame: Up to week 56 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Memorial Health ServiceFountain ValleyCalifornia92708-
University of California Los AngelesLos AngelesCalifornia10911-
The University of ChicagoChicagoIllinois60637-
Children's Hospital Corporation d/b/a Boston Children's HospitalBostonMassachusetts02115-
Children's Hospital Medical CenterCincinnatiOhio45229-
Board of Regents of the University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Baylor College of Medicine HoustonHoustonTexas77030-
The University of Texas Health Science Center at San AntonioSan AntonioTexas78229-3901-
Seattle Children's Hospital d/b/a Seattle Children's Research InstituteSeattleWashington98105-

Find similar trials in Fountain Valley, CA

By research site
Memorial Health Service· Fountain Valley, CAUniversity of California Los Angeles· Los Angeles, CAThe University of Chicago· Chicago, ILChildren's Hospital Corporation d/b/a Boston Children's Hospital· Boston, MAChildren's Hospital Medical Center· Cincinnati, OHBoard of Regents of the University of Oklahoma Health Sciences Center· Oklahoma City, OK

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