Compassionate Use of Omegaven in the Treatment of Parenteral Nutrition Induced Hepatic Injury

NCT ID: NCT02010034

Last Updated: 2019-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2019-02-05

Brief Summary

This study is being done to determine if an investigational study drug called Omegaven can help to improve liver disease thought to be caused by Total Parenteral Nutrition (TPN). TPN is intravenous feeding (IV feeding tube) that provides patients the nutrients when they are unable to drink fluid or eat food by mouth.

Detailed Description

PAtients with direct bilirubin >2gm/dL and short bowel syndrome are eligible for enrollment. Omegaven at 1gm/kg/day will be administered via central venous line instead of standard lipid preparations.

Conditions

Liver Disease; Impaired Liver Function; Parenteral Nutrition Associated Liver Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Compassionate use

This lipid preparation is only being used for compassionate use.

Group Type: OTHER

Omegaven

Intervention Type: DRUG

Omegaven will be used in place of soy oil Intralipid

Interventions

Omegaven

Omegaven will be used in place of soy oil Intralipid

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients must be 2 months -10 years of age

2. Patients who are PN dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require PN for at least another 30 days

3. Patients considered eligible for study participation must have parenteral nutrition associated liver disease (PNALD) as defined by a direct bilirubin of >2.0mg/dL. Other causes of liver disease should be excluded. A liver biopsy is not necessary for treatment

4. 2 consecutive direct bilirubin test results >2.0mg/dl

5. The patient must have failed standard therapies to prevent the progression of liver disease such as surgical treatment, cyclic TPN, avoiding overfeeding, reduction/removal of copper and manganese from TPN, advancement of enteral feeding, and use of ursodiol (Actigall)

6. Subjects who are currently under treatment for PNALD with Compassionate Use Omegaven and have a direct Bilirubin of< 2, but who remain TPN dependent and require continued therapy with Omegaven

Exclusion Criteria

1. Other known causes of chronic liver disease (hepatitis C, cystic fibrosis, biliary atresia and alpha 1 anti-trypsin deficiency)

2. Enrollment in any other clinical trial involving an investigational agent (unless approved by the designated physicians on the multidisciplinary team)

3. The parent, guardian, or child is unwilling to provide consent or assent

4. Allergy to any fish product, egg protein, and/or previous allergy to Omegaven

5. Active coagulopathies characterized by on-going bleeding or by a requirement for clotting factor replacement such as fresh frozen plasma or cryoprecipitate to maintain homeostasis

6. Impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis

7. Unstable diabetes mellitus

8. Stroke/embolism

9. Collapse and shock

10. Undefined coma status

11. Active infection at time of initiation of Omegaven® up until such time as child is afebrile with stable vital signs and one negative 48 hour culture

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Medical Center Dallas

OTHER

Sponsor Role: lead

Responsible Party

Nandini Channabasappa, MD

Director, Intestinal Rehabilitation Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nandini Channabasappa, MD

Role: PRINCIPAL_INVESTIGATOR

Childrens Health

Locations

Children's Medical Center of Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 112010-159

Identifier Type: -

Identifier Source: org_study_id