Leukaemia Trial, Recruiting NCT06274788 Sponsor: Fresenius Kabi Condition: Leukaemia
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Leukaemia Trial, Recruiting

NCT06274788
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • A parent or legal guardian has signed and dated the consent form agreeing to their child's participation.
  • The child is under 18 years old and has been diagnosed with a liver condition called PNAC (parenteral nutrition-associated cholestasis), meaning their liver is not working properly due to being fed through an IV line, with no other known cause for the liver problem — and they are expected to need the study treatment (Omegaven) for at least 8 weeks.
  • The child cannot tolerate being fed by mouth or through a feeding tube, or has at least one digestive system problem that requires them to be fed through an IV line.

Who may not be able to join:

  • The child has received the study drug (Omegaven) within the last four weeks.
  • The child has another known cause of long-term liver disease, such as hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, or liver problems caused by heart failure.
  • The child has been diagnosed with cirrhosis (severe scarring of the liver).
  • The child has been diagnosed with, or has shown signs of, a blood clot in the portal vein (a major vein that carries blood to the liver).
  • The child has previously had a liver transplant (either liver alone or liver along with another organ).
  • The child has an unstable heart condition that affects blood flow throughout the body.
  • The child has a serious, life-threatening illness such as severe blood infection (sepsis) requiring high-level medications, severe lung failure, or cancer.
  • The child has multiple organ failure, severe low blood pressure, serious lung pressure problems, or requires a machine to support their heart and lung function (such as ECMO).
  • The child has kidney failure that requires a machine to do the work of the kidneys (dialysis or similar treatment).
  • The child has a serious bleeding disorder.
  • The child has very high levels of fats (specifically triglycerides) in their blood, above 1,000 mg/dL.
  • The child has a history of essential fatty acid deficiency (a condition where the body lacks certain important fats) before joining the study.
  • The child has been diagnosed with, or is suspected to have, an inherited condition affecting how their body processes food and nutrients (inborn error of metabolism).
  • The child is allergic to fish, egg protein, or any ingredient in Omegaven.
  • The child is subject to any limitations on their medical treatment (confirm with trial site).
  • The child is currently taking part in another clinical trial involving an experimental medication.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: M +49 173 5439924

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Fresenius Kabi
Registry
ClinicalTrials.gov
Start date
15 December 2024
Est. completion
1 March 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of essential fatty acid deficiency (EFAD)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov