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NCT01845116 · ClinicalTrials.gov registry record · Phase 2
Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01845116 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 11 participants.
The verdict
NCT01845116, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children. The study hypothesis is that Omegaven® can be safely provided to children who are dependent on parenteral nutrition and have PNALD, and can reverse or prevent progression of PNALD until the child can take adequate nutrition by mouth.
Interventions
- DRUG Omegaven®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2010-07 |
| Est. Completion | 2020-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01845116
The ClinicalTrials.gov registry entry for NCT01845116 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Omegaven® is the first listed.
NCT01845116 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01845116 about?
NCT01845116 is a clinical study titled "Omegaven® in the Treatment of Parenteral Nutrition (PN) Induced Liver Injury". The purpose of this study is to determine whether the omega-3 fatty acid emulsion (Omegaven®), when used in place of the conventional soy-based fat emulsion (Intralipid), is effective in treating parenteral nutrition associated liver disease (PNALD) in children. The study hypothesis is that Omegave...
What is the current status of trial NCT01845116?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2010-07. Estimated completion is 2020-07.
What interventions are being tested in trial NCT01845116?
The interventions under investigation include: Omegaven® (DRUG).
Who is sponsoring clinical trial NCT01845116?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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