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

• Sponsor: Midwestern Regional Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01325584
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 54
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer; Hepatic Injury	Drug: Omegaven	Phase 2

Detailed 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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Omegaven (compassionate use) This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.

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.; Other Names: fish oil

Outcome Measures

Primary Outcome Measures

1. Maximum Conjugated Bilirubin [Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.]

   Highest detected lab values will be summarized between baseline and end of study participation.

2. Average Change in Alkaline Phosphatase [Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.]

   lab values will be summarized at baseline and as change from baseline to worst follow-up value.

3. Number of Patients Experiencing Adverse Events [Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.]

   The number of patients reporting or experiencing adverse effects will be reported.

4. Average Improvement in AST [Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.]

   Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.

5. Average Improvement in ALT [Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.]

   Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Treatment Centers of America at Midwestern Regional Medical Center	Zion	Illinois	United States	60099

Sponsors and Collaborators

• Midwestern Regional Medical Center

Investigators

• Principal Investigator: Pankaj Vashi, MD, Midwestern Regional Medical Center

Study Documents (Full-Text)

• Study Protocol - Feb 4, 2011

More Information

Publications

None provided.

• Responsible Party: Pankaj Vashi, MD, Lead National Medical Director, National Director Gastroenterology, Nutrition & Metabolic Support, Midwestern Regional Medical Center
• ClinicalTrials.gov Identifier: NCT01325584
• Other Study ID Numbers: MRMC 10-06
• First Posted: Mar 30, 2011
• Last Update Posted: Aug 7, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	Omegaven (Compassionate Use)
Arm/Group Description	This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. 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.
Period Title: Overall Study
STARTED	12
COMPLETED	11
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Omegaven (Compassionate Use)
Arm/Group Description	This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. 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.
Overall Participants	12
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	12 100%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58 (10.2)
Sex: Female, Male (Count of Participants)
Female	9 75%
Male	3 25%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	12 100%

Outcome Measures

1. Primary Outcome

Title	Maximum Conjugated Bilirubin
Description	Highest detected lab values will be summarized between baseline and end of study participation.
Time Frame	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omegaven (Compassionate Use)
Arm/Group Description	This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. 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.
Measure Participants	11
Mean (Standard Deviation) [mg/dl]	1.0 (0.1)

2. Primary Outcome

Title	Average Change in Alkaline Phosphatase
Description	lab values will be summarized at baseline and as change from baseline to worst follow-up value.
Time Frame	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

Outcome Measure Data

Analysis Population Description

Average Improvement in Alkaline Phosphatase

Arm/Group Title	Omegaven (Compassionate Use)
Arm/Group Description	This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. 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.
Measure Participants	11
Baseline	457.6
4 Week Nadir	360.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omegaven (Compassionate Use)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.07
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	Number of Patients Experiencing Adverse Events
Description	The number of patients reporting or experiencing adverse effects will be reported.
Time Frame	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omegaven (Compassionate Use)
Arm/Group Description	This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. 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.
Measure Participants	11
Count of Participants [Participants]	1 8.3%

4. Primary Outcome

Title	Average Improvement in AST
Description	Lab values will be summarized at b aselin4e and as change from baseline to worst follow-up value.
Time Frame	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omegaven (Compassionate Use)
Arm/Group Description	This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. 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.
Measure Participants	11
Baseline	88.7
4 Weeks Nadir	69.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omegaven (Compassionate Use)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.53
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Primary Outcome

Title	Average Improvement in ALT
Description	Laboratory values will be summarized at baseline and as change from baseline to worst follow-up value
Time Frame	Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omegaven (Compassionate Use)
Arm/Group Description	This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. 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.
Measure Participants	11
Baseline	133.6
4 Weeks Nadir	101.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Omegaven (Compassionate Use)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.48
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Arm/Group Title	Omegaven (Compassionate Use)
Arm/Group Description	This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks. 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.
All Cause Mortality
	Omegaven (Compassionate Use)
	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)
Serious Adverse Events
	Omegaven (Compassionate Use)
	Affected / at Risk (%)	# Events
Total	0/11 (0%)
Other (Not Including Serious) Adverse Events
	Omegaven (Compassionate Use)
	Affected / at Risk (%)	# Events
Total	1/11 (9.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression	1/11 (9.1%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.