Cholestasis Reversal: Efficacy of IV Fish Oil

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

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2019-01-23

Brief Summary

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

The purpose of this study is to determine whether Omegaven is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

Related Clinical Trials

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

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

NCT00826020

Parenteral Nutrition Associated Liver Disease PNALD Cholestasis

COMPLETED PHASE2

Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis

NCT01173159

Cholestasis

COMPLETED NA

Intravenous Fish Oils in the Treatment of Parenteral Nutrition Liver Injury

NCT02780193

Cholestasis Total Parenteral Nutrition-induced Cholestasis

APPROVED_FOR_MARKETING

Cholestasis Prevention: Efficacy of IV Fish Oil

NCT00512629

Cholestasis Parenteral Nutrition

COMPLETED PHASE1

Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease

NCT01739517

Short Bowel Syndrome Cholestasis

UNKNOWN PHASE2

Detailed Description

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

The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven), when used in lieu of the conventional soy-based fat emulsion (Intralipid), is effective in the treatment of parenteral nutrition associated liver disease (PNALD).

Conditions

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

Parenteral Nutrition Associated Liver Disease Short Bowel Syndrome Gastrointestinal Disease

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

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.

Omegaven

1g/kg/day for duration of study participation for all participants

Group Type EXPERIMENTAL

Omegaven®

Intervention Type DRUG

10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated

Interventions

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

Omegaven®

10% Omegaven® 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated

Intervention Type DRUG

Other Intervention Names

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

Fish Oil Lipid Emulsion (FOLE)

Eligibility Criteria

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

Inclusion Criteria

1. Patients will be PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days
2. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined as a direct bilirubin of \> 2 mg/dl or currently on Omegaven through another protocol. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment.
3. Direct bilirubin \> 2.0 mg/dl or already on Omegaven through another protocol
4. Signed patient informed consent.
5. The patient must have utilized standard therapies to prevent the progression of his/her liver disease including surgical treatment, cyclic PN, avoiding overfeeding, reduction/removal of copper and manganese from PN, advancement of enteral feeding, and the use of ursodiol (i..e., Actigall®).

Exclusion Criteria

1. Pregnancy
2. Other causes of chronic liver disease (Hepatitis C, biliary atresia, and alpha 1 anti-trypsin deficiency).
3. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)
4. The parent or guardian or child unwilling to provide consent or assent

In rare instances, patients diagnosed with PNALD may later be found to have liver disease due to other causes in addition to the use of PN (i.e., inborn errors of metabolism, viral infections ). Such causes may not be known at the time of enrollment and will not preclude them from continuing in the study. For the sake of statistical analysis, however, these patients will be excluded although all data will be collected and reviewed.

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No