Clinical trial · Interventional
Compassionate Use of Omegaven® in the Treatment of Parenteral Nutrition Induced Hepatic Injury
NCT01325584CI-TRIAL-00034157terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Alternative product is now approved and available for use.
Summary
Brief summary (as posted)
The purposes of this study are to make Omegaven® available to cancer patients with liver disease and to determine if Omegaven® can improve or prevent further liver disease. The study will also look at the effects Omegaven® has on immune function.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Hepatic Injury | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omegaven | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omegaven (compassionate use)
- description
- This is a compassionate use study. All participants will receive intravenous Omegaven (10% fish oil emulsion) with parenteral nutrition for 4 weeks.
- interventionNames
- Drug: Omegaven
Primary outcomes (5)
- measure
- Maximum Conjugated Bilirubin
- timeFrame
- Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
- description
- Highest detected lab values will be summarized between baseline and end of study participation.
- measure
- Average Change in Alkaline Phosphatase
- timeFrame
- Assessed at day 1, 2, 3, and weekly therafter, up to 4 weeks.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or Female; ages 18 to 80 years old 2. Receiving treatment at Cancer Treatment Centers of America 3. Receiving PN (either in the infusion center or at home) 4. Have existing hepatic dysfunction defined as Elevation of \> 3x the normal level of one or more of the following:Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), or Alanine Aminotransferase ALT) and/or Bilirubin \> 2 mg/dl in the absence of biliary obstruction 5. Able to provide informed written consent Exclusion Criteria: 1. Hypertriglyceridemia (triglycerides \[TG\] \> 400) 2. Allergy to fish or egg protein 3. Currently on therapeutic doses of Coumadin, heparin, or low molecular eight heparin 4. Hemodynamically unstable 5. Bilirubin \> 5 mg/dL 6. Documented liver metastases 7. Unstable diabetes with known diabetic ketoacidosis within 7 days of screening 8. Recent cardiac infarction (within 6 months) and taking plavix 9. Severe hemorrhagic disorders 10. Current anticoagulation therapy for deep venous thromboembolism or pulmonary embolism 11. Active sepsis 12. Undefined coma status 13. In patients with abnormal kidney function, renal insufficiency with calculated creatinine clearance \< 30 mL/min 14. Pregnancy or lactation
References
Publications (0)
Data not yet available
No reference posted for this study.