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NCT02309411 · ClinicalTrials.gov registry record · Phase 2
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
A Phase 2 study of Venous Thromboembolism, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 20
- Study locations
NCT02309411: Completed Phase 2 study of Venous Thromboembolism, sponsored by Bayer.
NCT02309411 is a Phase 2 study of Venous Thromboembolism that has completed, run by Bayer. The registered enrollment target is 46 participants, below the 6,295-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02309411, a Phase 2 study of Venous Thromboembolism, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
Primary Outcome
Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or * leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or * occurring in a critical site, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. Clinically relevant non-major bleeding is defi
Conditions Studied
Interventions
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
Study Locations (20)
Other
- - Vienna
- - São Paulo
- - Budapest
- - Jerusalem
- - Ramat Gan
- - Nijmegen
- - Gdansk
- - Olsztyn
Florida
- - Gainesville
- - Pensacola
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- - Chicago
Indiana
- - Indianapolis
Victoria
- - Parkville
São Paulo
- - São Paulo
Ontario
- - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2015-01-15 |
| Est. Completion | 2017-04-05 |
| Phase | Phase 2 |
What the finished NCT02309411 record still lists
NCT02309411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 6,295-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Venous Thromboembolism appearing as the primary indexed condition, and to 1 intervention - of which Rivaroxaban (Xarelto, BAY59-7939) is the first listed.
NCT02309411 names 20 study sites across 12 states, led by Other, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02309411 about?
NCT02309411 is a clinical study titled "EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis". The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
What is the current status of trial NCT02309411?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2015-01-15. Estimated completion is 2017-04-05.
What conditions does trial NCT02309411 study?
This clinical trial studies the following conditions: Venous Thromboembolism.
What interventions are being tested in trial NCT02309411?
The interventions under investigation include: Rivaroxaban (Xarelto, BAY59-7939) (DRUG).
Who is sponsoring clinical trial NCT02309411?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02309411 being conducted?
This trial has 20 study locations across Florida, Georgia, Illinois, Indiana, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02309411's enrollment target sits among peer trials
46 43rd of 47 higher than 5 of 47 other Venous Thromboembolism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Thromboembolism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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