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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01325584
• Other study ID #: MRMC 10-06
• Status: Terminated
• Phase: Phase 2
• Start date: October 2012
• Est. completion date: April 2017

Study information

• Verified date: July 2018
• Source: Midwestern Regional Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.

Description:

This compassionate use study will include patients with advanced cancer requiring PN for long-term nutrition support who have developed PN-induced hepatic injury or who have existing hepatic dysfunction. Therapy with Omegaven will be provided at an initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. For patients > 120% ideal body weight, adjusted body weight will be used. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Omegaven will be co-administered via a y-site infusion, with containers being changed every 12 hours. The patient may receive other lipids to meet Essential Fatty Acid (EFA) and/or additional calorie needs. Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. If an adverse reaction is observed, IV steroids & benadryl will be administered & Omegaven will be discontinued. Patients will continue to receive infusions at CTCA for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home with Coram. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month (see Table 2).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or Female; ages 18 to 80 years old

2. Receiving treatment at Cancer Treatment Centers of America

3. Receiving PN (either in the infusion center or at home)

4. Have existing hepatic dysfunction defined as Elevation of > 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin > 2 mg/dl in the absence of biliary obstruction

5. Able to provide informed written consent

Exclusion Criteria:

1. Hypertriglyceridemia (triglycerides [TG] > 400)

2. Allergy to fish or egg protein

3. Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin

4. Hemodynamically unstable

5. Bilirubin > 5 mg/dL

6. Documented liver metastases

7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening

8. Recent cardiac infarction (within 6 months) and taking plavix

9. Severe hemorrhagic disorders

10. Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism

11. Active sepsis

12. Undefined coma status

13. In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance < 30 mL/min

14. Pregnancy or lactation

Related Conditions & MeSH terms

• Cancer
• Hepatic Injury
• Wounds and Injuries

Intervention

Drug:
• Omegaven
initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.

Locations

Country	Name	City	State
United States	Cancer Treatment Centers of America at Midwestern Regional Medical Center	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Conjugated Bilirubin	Highest detected lab values will be summarized between baseline and end of study participation.	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Primary	Average Change in Alkaline Phosphatase	lab values will be summarized at baseline and as change from baseline to worst follow-up value.	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Primary	Number of Patients Experiencing Adverse Events	The number of patients reporting or experiencing adverse effects will be reported.	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Primary	Average Improvement in AST	Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Primary	Average Improvement in ALT	Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.