Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02476994
Recruitment Status : Terminated (Based on feedback from FDA)
First Posted : June 22, 2015
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Essential Fatty Acid Deficiency (EFAD)
Interventions Drug: Clinolipid
Drug: Intralipid
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Period Title: Overall Study
Started 1 0
Completed 0 0
Not Completed 1 0
Reason Not Completed
Based on feedback from FDA             1             0
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP) Total
Hide Arm/Group Description

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Total of all reporting groups
Overall Number of Baseline Participants 1 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
<=18 years
1
 100.0%
0
1
 100.0%
Between 18 and 65 years
0
   0.0%
0
0
   0.0%
>=65 years
0
   0.0%
0
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
Female
1
 100.0%
0
1
 100.0%
Male
0
   0.0%
0
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 1 participants
American Indian or Alaska Native
0
   0.0%
0
0
   0.0%
Asian
0
   0.0%
0
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
0
   0.0%
Black or African American
0
   0.0%
0
0
   0.0%
White
1
 100.0%
0
1
 100.0%
More than one race
0
   0.0%
0
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
0
   0.0%
1.Primary Outcome
Title Essential Fatty Acid Deficiency (EFAD)
Hide Description Holman Index Calculation
Time Frame Up to 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Parenteral Nutrition-Associated Cholestasis (PNAC)
Hide Description [Not Specified]
Time Frame Up to 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Genetic Polymorphisms in Fatty Acid Desaturase Genes FADS1 and FADS2
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Fatty Acid Profile
Hide Description [Not Specified]
Time Frame Up to 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Weight
Hide Description [Not Specified]
Time Frame Up to 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Phytosterol, Cholesterol, and Squalene Levels
Hide Description [Not Specified]
Time Frame Up to 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline of Hepatic Integrity (ALP, AST, ALT, GGT, Total and Direct Bilirubin)
Hide Description [Not Specified]
Time Frame Up to 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Prescribed and Actual (Total Calories From PN and Oral) Nutritional Intake
Hide Description [Not Specified]
Time Frame Up to 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Vital Signs
Hide Description [Not Specified]
Time Frame Up to 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Adverse Events and Serious Adverse Events
Hide Description [Not Specified]
Time Frame Up to 30 Days After Subject's Last Study Treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Clinical Laboratory Tests
Hide Description [Not Specified]
Time Frame Up to 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Due to early termination of the study, no formal analysis was conducted.
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description:

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Hide Arm/Group Description

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Clinolipid

Dosing schedule based on subject's age, weight, and medical condition and as per ESPEN-ESPHAN guidelines.

Intralipid: Standard-of-Care Soybean Oil-Based Lipid Emulsion

All-Cause Mortality
Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clinolipid (Lipid Injectable Emulsion, USP) 20% Intralipid 20% (Lipid Injectable Emulsion, USP)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0 
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Disclosure Group
Organization: Baxter Healthcare
EMail: joe_archer@baxter.com
Layout table for additonal information
Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT02476994     History of Changes
Other Study ID Numbers: 6344-001
First Submitted: June 16, 2015
First Posted: June 22, 2015
Results First Submitted: October 31, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017