Phase 3
N=2
Omegaven as Alternative Parenteral Fat Nutrition
Cholestasis · Cholestasis of Parenteral Nutrition
Bottom Line
View on ClinicalTrials.gov: NCT03662282 ↗Enrolled (actual)
2
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participant With Decrease in Direct Bilirubin Level — 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omegaven (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant With Decrease in Direct Bilirubin Level |
2; 0 | — |
| SECONDARY Number of Participant With Resolution of Direct Hyperbilirubinemia |
1; 1 | — |
| SECONDARY Number of Participant With Preservation of Length |
2; 0 | — |
| SECONDARY Number of Participant With Preservation of Head Circumference |
2; 0 | — |
| SECONDARY Number of Participant With Preservation of Normal Weight Gain |
2; 0 | — |
Summary
To provide Omegaven® as a compassionate treatment for critically ill infants with parenteral nutrition associated cholestasis
Eligibility Criteria
Inclusion Criteria
- Greater than 14 days old
- Has parenteral nutrition associated cholestasis defined as at least 2 consecutive direct bilirubin >2 mg/dL with anatomical or functional short gut (OR >4 mg/dL if intact intestine) obtained at least 1 week apart with a ratio of direct: total bilirubin > 0.4
- Patient is parenteral nutrition dependent (unable to meet nutritional needs solely by enteral nutrition) and are expected to require parenteral nutrition for at least 3 more weeks
- Patient has not responded to other therapeutic approaches for parenteral nutrition-associated liver disease such as : cycling of parenteral nutrition, avoiding overfeeding, reduction/removal of copper and manganese from parenteral nutrition, advancement of enteral feeding, and use of Ursodiol
- Patient has been on at least 2 weeks of SMOFLIPIDs with no improvement or worsening of direct bilirubin levels
- Signed patient informed consent
- The patient is expected to have a reasonable possibility of survival
- No other known etiology of cholestasis other than parenteral nutrition-associated liver disease at the time of Omegaven® initiation
Exclusion Criteria
- Known causes of cholestasis other than parenteral nutrition-associated liver disease including but not limited to Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 antitrypsin deficiency are present, prior to Omegaven® initiation
- Known fish or egg allergy
- Any of the contraindications to use of Omegaven®:
- Active new infection at the time of initiation of Omegaven®
- Hemodynamic instability
- Recent use of medications with associated risk of bleeding, including NSAIDs
- Active coagulopathy or bleeding
- Platelet counts persistently under 30, 000 despite transfusions
- Unstable hyperglycemia
- Impaired lipid metabolism (triglycerides >1000 mg/dL) while on 1 g/kg/day or less of Intralipid
- History of severe hemorrhagic disorders (ie. hemophilia, Von Willebrand disease, etc.)
- Unstable diabetes mellitus
- Collapse and shock
- Stroke/ Embolism
- Cardiac infarction within the last 3 months
- Undefined coma status
Data sourced from ClinicalTrials.gov (NCT03662282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.