Trial Outcomes & Findings for Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury (NCT NCT01325584)
NCT ID: NCT01325584
Last Updated: 2018-08-07
Results Overview
Highest detected lab values will be summarized between baseline and end of study participation.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
Results posted on
2018-08-07
Participant Flow
Participant milestones
| Measure |
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.
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.
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|---|---|
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Overall Study
STARTED
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12
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
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.
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.
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Overall Study
Death
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1
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Omegaven (Compassionate Use)
n=12 Participants
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.
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Age, Categorical
<=18 years
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0 Participants
n=12 Participants
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Age, Categorical
Between 18 and 65 years
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12 Participants
n=12 Participants
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Age, Categorical
>=65 years
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0 Participants
n=12 Participants
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Age, Continuous
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58 Years
STANDARD_DEVIATION 10.2 • n=12 Participants
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Sex: Female, Male
Female
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9 Participants
n=12 Participants
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Sex: Female, Male
Male
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3 Participants
n=12 Participants
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Region of Enrollment
United States
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12 Participants
n=12 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Omegaven (Compassionate Use)
n=11 Participants
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.
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|---|---|
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Maximum Conjugated Bilirubin
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1.0 mg/dl
Standard Deviation 0.1
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PRIMARY outcome
Timeframe: Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.Population: Average Improvement in Alkaline Phosphatase
lab values will be summarized at baseline and as change from baseline to worst follow-up value.
Outcome measures
| Measure |
Omegaven (Compassionate Use)
n=11 Participants
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.
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Average Change in Alkaline Phosphatase
Baseline
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457.6 U/L
Interval 390.0 to 1006.0
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Average Change in Alkaline Phosphatase
4 Week Nadir
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360.4 U/L
Interval 193.0 to 723.0
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Omegaven (Compassionate Use)
n=11 Participants
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.
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|---|---|
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Number of Patients Experiencing Adverse Events
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1 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Omegaven (Compassionate Use)
n=11 Participants
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.
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|---|---|
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Average Improvement in AST
Baseline
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88.7 U/L
Interval 31.0 to 402.0
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Average Improvement in AST
4 Weeks Nadir
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69.9 U/L
Interval 24.0 to 160.0
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PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Omegaven (Compassionate Use)
n=11 Participants
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.
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|---|---|
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Average Improvement in ALT
Baseline
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133.6 U/L
Interval 29.0 to 456.0
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Average Improvement in ALT
4 Weeks Nadir
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101.4 U/L
Interval 15.0 to 336.0
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Adverse Events
Omegaven (Compassionate Use)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omegaven (Compassionate Use)
n=11 participants at risk
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.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
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9.1%
1/11 • Number of events 1
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Additional Information
Director of Clinical Trials
Midwestern Regional Medical Center
Phone: 847-731-1648
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place