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NCT00738101 · ClinicalTrials.gov registry record · NA
Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants
A NA study of Cholestasis and Cholestasis of Parenteral Nutrition, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 293
- Enrollment target
- 2
- Study locations
NCT00738101: Completed NA study of Cholestasis and Cholestasis of Parenteral Nutrition, sponsored by Baylor College of Medicine.
NCT00738101 is a NA study of Cholestasis and Cholestasis of Parenteral Nutrition that has completed, run by Baylor College of Medicine. The registered enrollment target is 293 participants, above the 109-participant average among 6 other Cholestasis trials with a reported enrollment target (169% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00738101, a NA study of Cholestasis and Cholestasis of Parenteral Nutrition, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 293 participants
- Enrollment target
- 2
- Study locations
Study Summary
To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
Primary Outcome
Time in days from the initiation of fish oil emulsions (initiation of study) until resolution of cholestasis as defined by serum conjugated bilirubin≤ 2 mg/dL prior to EOS (end of study).
Conditions Studied
Interventions
- DRUG Omegaven
Study Locations (2)
Texas
- Baylor College of Medicine - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 293 participants |
| Start Date | 2008-09 |
| Est. Completion | 2020-03-27 |
| Phase | NA |
What the finished NCT00738101 record still lists
NCT00738101 is an interventional study that assigns participants to a tested intervention. The registered 293 participants enrollment target is mid-sized for trials with a published cap, above the 109-participant average among 6 other Cholestasis trials with a reported enrollment target (169% higher).
The record links to 2 conditions, with Cholestasis appearing as the primary indexed condition, and to 1 intervention - of which Omegaven is the first listed.
NCT00738101 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT00738101 about?
NCT00738101 is a clinical study titled "Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants". To provide a mechanism for critically ill infants with parenteral nutrition (PN) associated cholestasis to receive Omegaven for compassionate use situations for which there are no satisfactory alternative treatments.
What is the current status of trial NCT00738101?
This trial is currently completed. It is a NA study. The enrollment target is 293 participants. The study started on 2008-09. Estimated completion is 2020-03-27.
What conditions does trial NCT00738101 study?
This clinical trial studies the following conditions: Cholestasis, Cholestasis of Parenteral Nutrition.
What interventions are being tested in trial NCT00738101?
The interventions under investigation include: Omegaven (DRUG).
Who is sponsoring clinical trial NCT00738101?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00738101 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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