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Omegaven for Bone Marrow Transplant

Phase 1
Waitlist Available
Led By Alexandra N Carey, MD
Research Sponsored by Alexandra N. Carey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weekly for 4 weeks, 30 & 100 days following stem cell transplantation
Awards & highlights

Study Summary

This trial is testing whether fish oil lipid emulsion (FOLE), rich in omega-3 fatty acids, is safe and tolerated in children undergoing hematopoietic cell transplantation (HCT) for cancer or blood disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weekly for 4 weeks, 30 & 100 days following stem cell transplantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weekly for 4 weeks, 30 & 100 days following stem cell transplantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Essential fatty acid levels
Triglyceride levels
Other outcome measures
Body composition
Inflammatory markers
Quality of life assessment

Side effects data

From 2019 Phase 4 trial • 48 Patients • NCT00862446
10%
Hypertriglyceridemia
2%
Coagulopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Omegaven Treatment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fish Oil Lipid EmulsionExperimental Treatment1 Intervention
1 g/kg intravenous fish oil lipid emulsion (Omegaven) daily, provided starting day of transplant through day 30 or hospital discharge, whichever comes first.
Group II: Soybean Oil Lipid EmulsionActive Control1 Intervention
1 g/kg intravenous soybean oil lipid emulsion (SOLE) daily, provided starting day of transplant through day 30 or hospital discharge, whichever comes first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omegaven
2020
Completed Phase 4
~640

Find a Location

Who is running the clinical trial?

Alexandra N. CareyLead Sponsor
Christopher Duggan, MD, MPHStudy DirectorBoston Children's Hospital
2 Previous Clinical Trials
96 Total Patients Enrolled
Alexandra N Carey, MDPrincipal InvestigatorBoston Children's Hospital

Media Library

Omegaven Clinical Trial Eligibility Overview. Trial Name: NCT02512718 — Phase 1
Bone Marrow Transplant Research Study Groups: Soybean Oil Lipid Emulsion, Fish Oil Lipid Emulsion
Bone Marrow Transplant Clinical Trial 2023: Omegaven Highlights & Side Effects. Trial Name: NCT02512718 — Phase 1
Omegaven 2023 Treatment Timeline for Medical Study. Trial Name: NCT02512718 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is this trial recruiting?

"Affirmative, the information hosted by clinicaltrials.gov reveals that this research is actively recruiting patients. The trial was announced on June 1st 2016 and its parameters have been updated as recently as June 9th 2022; 20 participants need to be found from one medical facility."

Answered by AI

In what clinical scenarios is Omegaven commonly utilized?

"Omegaven is primarily employed to tackle parenteral nutrition, yet it may also be utilized for dietary supplementation or post-natal nutritional therapies."

Answered by AI

Are researchers still recruiting for this experiment?

"This clinical trial, posted on June 1st 2016 and updated on the 9th of last month, is actively seeking volunteers. The data available through clinicaltrials.gov reflect this."

Answered by AI

Are there any precedents of Omegaven being implemented in other clinical trials?

"At the moment, 17 clinical trials are testing the efficacy of Omegaven. 3 of those experiments have progressed to Phase 3 and there are 32 sites offering this treatment - predominantly situated in Ciudad De Mexico, Mexico."

Answered by AI

Does my profile fit the criteria necessary to participate in this research?

"The study is limited to children between two and eighteen years old with a hematopoietic stem cell count within the normal range. The trial will likely admit 20 participants in total."

Answered by AI

Has the Omegaven medication been given authorization by the FDA?

"The safety rating of Omegaven was set at 1 due to the limited evidence available from this early-phase trial. There is only minimal data demonstrating its efficacy and security."

Answered by AI

Does this trial accept participants who are younger than 65 years old?

"To participate in this medical trial, the patient's age must fall between 2 and 18 years old. Of those qualified for enrolment, 30 are younger than 18 while 41 patients have surpassed 65 years of age."

Answered by AI
~2 spots leftby Mar 2025