Boston, MANCT06274788Now EnrollingIRB Ready

Parenteral Nutrition Associated Liver Disease (PNALD) Clinical Trial in Boston, MA

Access cutting-edge parenteral nutrition associated liver disease (pnald) treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Fresenius Kabi

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Expert Care in Boston

Access parenteral nutrition associated liver disease (pnald) specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related parenteral nutrition associated liver disease (pnald) treatment provided free

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Check if you qualify for this parenteral nutrition associated liver disease (pnald) clinical trial in Boston, MA

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Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Parenteral Nutrition Associated Liver Disease (PNALD) Study in Boston

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

Sponsor: Fresenius Kabi

Who Can Participate

Inclusion Criteria

Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF).
Pediatric patient (\<18 years) has been diagnosed with PNAC, defined as direct or conjugated bilirubin (DBil) ≥ 2.0 mg/dL with no other known cause of liver dysfunction at the time of enrollment and is expected to require Omegaven treatment for at least eight weeks.
Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN.

Exclusion Criteria

Patient has received Omegaven within four weeks before inclusion in the study
Patient has any other known cause of chronic liver disease such as hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion due to heart failure, etc.
Patient has known cirrhosis (liver biopsy is not required under this protocol).
Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis.
Patient has previously received a liver-only or liver-inclusive transplant.
Patient has hemodynamic instability due to any major cardiac anomaly.
Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).
Patient has multi-organ failure, septic shock, hypotension requiring pressor therapy, persistent pulmonary hypertension requiring inhaled nitric oxides, or requires extracorporeal membrane oxygenation (ECMO) or similar intervention.
Patient has renal failure and requires renal replacement therapy.
Patient has a severe hemorrhagic disorder.
Patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level \> 1,000 mg/dL).
Patient has a record of EFAD before inclusion in the study
Patient has been diagnosed with or is suspected to have an inborn error of metabolism.
Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven.
Patient is subject to treatment limitation.
Patient is enrolled in any other study with an investigational medicinal product during the course of the current study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT06274788) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Parenteral Nutrition Associated Liver Disease (PNALD) Treatment Options in Boston, MA

If you're searching for parenteral nutrition associated liver disease (pnald) treatment options in Boston, MA, this clinical trial (NCT06274788) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced parenteral nutrition associated liver disease (pnald) specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all parenteral nutrition associated liver disease (pnald) clinical trials near you to find additional studies recruiting in your area.

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