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COMPLETED NA

Compassionate Use of an Intravenous Fish Oil Emulsion in the Treatment of Liver Injury in Infants

NCT00738101 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Omegaven

Study Locations (2)

Texas

  • Baylor College of Medicine — Houston
  • Texas Children's Hospital — Houston

Trial Details

FieldValue
Enrollment Target 293 participants
Start Date 2008-09
Est. Completion 2020-03-27
Phase NA

Sponsor

Baylor College of Medicine

678 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00738101

The ClinicalTrials.gov registry entry for NCT00738101 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 293 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 678 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00738101 reports 2 study locations spanning 1 distinct geographic area — top geographies include Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00738101?

The interventions under investigation include: Omegaven (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00738101?

This trial is sponsored by Baylor College of Medicine, which has 678 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial