Trial Outcomes & Findings for Omegaven as Alternative Parenteral Fat Nutrition (NCT NCT03662282)

NCT ID: NCT03662282

Last Updated: 2020-07-22

Results Overview

Number of participant with decrease in direct bilirubin levels within 30 days of treatment

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2 participants
• Primary outcome timeframe: First month of treatment
• Results posted on: 2020-07-22

Participant Flow

Infants were recruited from a single NICU for compassionate use of Omegaven for cholestasis.

Infants were screened based on inclusion and exclusion criteria. When there was a potential candidate, an IND application is submitted to FDA.

Participant milestones

Measure	Drug - Omegaven® Participants were screened based on inclusion and exclusion criteria. If and when a participant was qualified for Omegaven treatment, we sent FDA and application for IND approval. After the approval, the participant received Omegaven daily per protocol until cholestatsis resolved.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Omegaven as Alternative Parenteral Fat Nutrition

Baseline characteristics by cohort

Measure	Drug - Omegaven® n=2 Participants These infants were more than one month old with history of long-term TPN dependence due to intestinal problem.
Age, Continuous	45 days n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: First month of treatment

Number of participant with decrease in direct bilirubin levels within 30 days of treatment

Outcome measures

Measure	Drug - Omegaven® n=2 Participants Omegaven treatment group
Number of Participant With Decrease in Direct Bilirubin Level decrease in bilirubin level	2 Participants
Number of Participant With Decrease in Direct Bilirubin Level increase or no change in bilirubin level	0 Participants

SECONDARY outcome

Timeframe: 2 months

Number of participant with Direct bilirubin level of <2mg/dL at discontinuation of treatment

Outcome measures

Measure	Drug - Omegaven® n=2 Participants Omegaven treatment group
Number of Participant With Resolution of Direct Hyperbilirubinemia bilirubin <2mg/dL at discontinuing of Omegaven	1 Participants
Number of Participant With Resolution of Direct Hyperbilirubinemia bilirubin >2mg/dL at discontinuing of Omegaven	1 Participants

SECONDARY outcome

Timeframe: Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment

Monitoring of weekly length while the patient is receiving Omegaven® treatment

Outcome measures

Measure	Drug - Omegaven® n=2 Participants Omegaven treatment group
Number of Participant With Preservation of Length Preservation of length growth	2 Participants
Number of Participant With Preservation of Length fail in length growth	0 Participants

SECONDARY outcome

Timeframe: Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment

Monitoring of weekly head circumference while the patient is receiving Omegaven® treatment

Outcome measures

Measure	Drug - Omegaven® n=2 Participants Omegaven treatment group
Number of Participant With Preservation of Head Circumference preservation of head circumference	2 Participants
Number of Participant With Preservation of Head Circumference Fail in head circumference growth	0 Participants

SECONDARY outcome

Timeframe: Weekly measurement during treatment. Evaluation every 30 days from treatment initiation until discontinuation of treatment, patient hospital discharge, whichever comes first, or up to 6 months following initiation of treatment

Monitoring of daily weight gain while the patient is on Omegaven®

Outcome measures

Measure	Drug - Omegaven® n=2 Participants Omegaven treatment group
Number of Participant With Preservation of Normal Weight Gain preservation of weight gain	2 Participants
Number of Participant With Preservation of Normal Weight Gain fail in weight gain	0 Participants

Adverse Events

Drug - Omegaven®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thao Ho

University of South Florida

Phone: 813-844-3437

Email: tho1@usf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place