Use of Omegaven for Treatment With Parenteral Nutrition Associated Liver Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To provide parenteral fat emulsion prepared from fish oil (omega-3 fatty acid emulsion, Omegaven®) to patients with liver disease (PNALD).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Compassionate Use of Omegaven® for the Treatment of Intestinal Failure Associated Liver Disease in Children

NCT02328768

Total Parenteral Nutrition-Induced Cholestasis

APPROVED_FOR_MARKETING

Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury

NCT01845116

Total Parenteral Nutrition-induced Cholestasis

COMPLETED PHASE2

Expanded Access of Omegaven IV Fat Emulsion to Infants and Children With PNALD

NCT02929303

Total Parenteral Nutrition-induced Cholestasis

APPROVED_FOR_MARKETING

Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury

NCT02780193

Cholestasis Total Parenteral Nutrition-induced Cholestasis

APPROVED_FOR_MARKETING

Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis

NCT00826020

Parenteral Nutrition Associated Liver Disease PNALD Cholestasis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parenteral Nutrition-related Hepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a compassionate use protocol for patients with PNALD who have failed traditional treatment to receive Omegaven through an IND.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Overall Study

Use of Omegaven for patients with parenteral nutrition associated liver disease.

Group Type EXPERIMENTAL

Omegaven

Intervention Type DRUG

Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Omegaven

Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

IV Fish Oil Based Lipid Emulsion

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition.
2. Patient will be \<18 years of age.
3. Direct bilirubin \> 2.0mg/dl
4. The patient must have failed standard therapies to prevent progression his/her liver disease.

Exclusion Criteria

1. Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency).
2. Patients who are allergic to eggs/shellfish
3. Patients who have severe hemorrhagic disorders.

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No