Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02084628 · ClinicalTrials.gov registry record · Phase 3
Magnetic Resonance Imaging of the Liver in Children 0-2 Months of Age With an Intravenous Injection of Eovist/Primovist Which is a Contrast Agent
A Phase 3 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT02084628 is a Phase 3 study that was terminated before completion, run by Bayer. The registered enrollment target is 1 participants.
The verdict
NCT02084628, a Phase 3 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. It has been marketed since 2004 and used in many countries all over the world. The baby will have blood tests before and after the imaging is done to make sure that there are no unexpected findings before and after the imaging. Also 3 blood samples up to 8 hours after the injection will be obtained in order to measure how much of the dye is in the blood. The baby will have an intravenous line which can be used for the blood samples and will not need to be stick for the blood samples. Several radiologists will evaluate the images. The family doctor will be contacted to find out what was the diagnosis and treatment after the results of the MRI were known. Six months after the study, the parent(s)/legal guardian(s) will be contacted to make sure the that baby did not have any problems, especially with the skin, joints and eyes.
Interventions
- DRUG Gadoxetate disodium (Eovist/Primovist, BAY86-4873)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02084628
The ClinicalTrials.gov registry entry for NCT02084628 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gadoxetate disodium (Eovist/Primovist, BAY86-4873) is the first listed.
NCT02084628 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02084628 about?
NCT02084628 is a clinical study titled "Magnetic Resonance Imaging of the Liver in Children 0-2 Months of Age With an Intravenous Injection of Eovist/Primovist Which is a Contrast Agent". This is an open-label, multi-center study involving babies 0-2 months of age who have liver problems (pathology) and need to have their liver and possibly, the bile ducts imaged using magnetic resonance imaging and injection of a contrast agent (dye). This agent is called Eovist. It has been markete...
What is the current status of trial NCT02084628?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2015-02. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02084628?
The interventions under investigation include: Gadoxetate disodium (Eovist/Primovist, BAY86-4873) (DRUG).
Who is sponsoring clinical trial NCT02084628?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.