Trial Outcomes & Findings for Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis (NCT NCT00826020)

NCT ID: NCT00826020

Last Updated: 2023-10-05

Results Overview

Whether or not the subject had an intestine-containing transplant or not

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 72 participants
• Primary outcome timeframe: Bi-weekly x4, then monthly until the completion of the study, for an overall average of 5.5 years follow-up for the cohort
• Results posted on: 2023-10-05

Participant Flow

Patient recruitment began May 1, 2008. The study was closed October 6, 2017

Participant milestones

Measure	Omegaven™ This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients. Omegaven™: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.
Overall Study STARTED	72
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Omegaven™ Parenteral Nutrition in Patients With Total Parenteral Nutrition (TPN)-Induced Cholestasis

Baseline characteristics by cohort

Measure	Omegaven™ n=72 Participants This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients. Omegaven™: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.
Age, Continuous	5.8 months STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Gestational Age (weeks)	31 weeks STANDARD_DEVIATION 5 • n=5 Participants
Weight (kg) at Treatment Start	4.61 kg STANDARD_DEVIATION 2.09 • n=5 Participants
Weight Z Score at Treatment Start	-1.60 z-score STANDARD_DEVIATION 1.91 • n=5 Participants
Length (cm) at Treatment Start	55 cm STANDARD_DEVIATION 10 • n=5 Participants
Length Z Score at Treatment Start	-2.09 z score STANDARD_DEVIATION 2.17 • n=5 Participants
Total Bilirubin (mg/dL) at Treatment Start	9.9 mg/dL STANDARD_DEVIATION 6.2 • n=5 Participants
Direct Bilirubin (mg/dL) at Treatment Start	6.2 mg/dL STANDARD_DEVIATION 3.9 • n=5 Participants
Serum aspartate aminotransferase (AST) at Treatment Start	187 U/L STANDARD_DEVIATION 137 • n=5 Participants
Serum alanine aminotransferase (ALT) at treatment Start	159 U/L STANDARD_DEVIATION 125 • n=5 Participants
Alkaline Phosphatase at Treatment Start	436 U/L STANDARD_DEVIATION 226 • n=5 Participants
Parenteral Nutrition (PN) Calories at Treatment Start (kCal/kg/d)	91 kCal/kg/d STANDARD_DEVIATION 11 • n=5 Participants
Enteral Calories at Treatment Start (kCal/kg/d)	8 kCal/kg/d STANDARD_DEVIATION 12 • n=5 Participants
Underlying Diagnosis Necrotizing enterocolitis	31 Participants n=5 Participants
Underlying Diagnosis Intestinal Atresia	8 Participants n=5 Participants
Underlying Diagnosis Gastroschisis	22 Participants n=5 Participants
Underlying Diagnosis Volvulus	5 Participants n=5 Participants
Underlying Diagnosis Microvillus inclusion disorder	4 Participants n=5 Participants
Underlying Diagnosis Intestinal Aganglionosis	1 Participants n=5 Participants
Underlying Diagnosis Mesenteric Ischemia	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Bi-weekly x4, then monthly until the completion of the study, for an overall average of 5.5 years follow-up for the cohort

Whether or not the subject had an intestine-containing transplant or not

Outcome measures

Measure

Omegaven™ n=72 Participants This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients. Omegaven™: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.

Number of Patients With Progression to Small Bowel Transplantation.

19 Participants

SECONDARY outcome

Timeframe: weekly x 4, then bi-weekly x4, then monthly until the completion of the study, with an average follow-up of 5.5 years for the study cohort

Of patients starting with elevated total serum bilirubin, the number that progress to normalization of serum total bilirubin in routine bloodwork

Outcome measures

Measure

Omegaven™ n=72 Participants This study will be a prospective, non-randomized, open-label study of Omegaven™ for provision of parenteral lipid calories. The study cohort, receiving the PN lipid at 1g/kg/day, will be compared to historical controls at UNMC where parenteral lipid calories were provided exclusively through soybean-based formulations. The study is planned to enroll 100 patients. The Intestinal Rehabilitation Program at UNMC sees between 20 and 30 new pediatric patients per year, with almost all being PN-dependent and over 75% presenting with a bilirubin ≥ 2mg/dL. Based on these calculations, we estimate 4-5 years to enroll 100 patients. Omegaven™: 10% Omegaven™, 50 or 100 mL bottle; 1gram/kg/day and is infused over 12-24 hours.

Number of Subjects With Reversal of Biochemical Cholestasis

56 Participants

Adverse Events

Omegaven™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Mercer

University of Nebraska Medical Center

Phone: 402-559-6955

Email: dmercer@unmc.edu

Results disclosure agreements

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