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NCT00812370 · ClinicalTrials.gov registry record · Phase 1
The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids
A Phase 1 study, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00812370 is a Phase 1 study that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 18 participants.
The verdict
NCT00812370, a Phase 1 study, has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Thrombosis is a significant medical complication in children with chronic diseases. The currently utilized treatments have many drawbacks which can lead to poor outcomes. More modern therapies are available but have not been systematically tested in children. This study will determine whether one such medication, bivalirudin is a safer and more effective alterative. This study will monitor what effects the drug has upon the child's body and how the body processes the study drug (absorption, metabolism and elimination). The study will also evaluate the drug's effectiveness by following how long it takes to dissolve the clot. The safety issues being monitored relate to any observations of major or minor bleeding episodes after taking the drug, and/or any other side effects.
Interventions
- DRUG Bivalirudin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-09 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00812370
The ClinicalTrials.gov registry entry for NCT00812370 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bivalirudin is the first listed.
NCT00812370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00812370 about?
NCT00812370 is a clinical study titled "The UNBLOCK Study: Utilization of Bivalirudin On Clots in Kids". Thrombosis is a significant medical complication in children with chronic diseases. The currently utilized treatments have many drawbacks which can lead to poor outcomes. More modern therapies are available but have not been systematically tested in children. This study will determine whether one su...
What is the current status of trial NCT00812370?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-09. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00812370?
The interventions under investigation include: Bivalirudin (DRUG).
Who is sponsoring clinical trial NCT00812370?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
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