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NCT03496883 · ClinicalTrials.gov registry record · Phase 3
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
A Phase 3 study of Intracerebral Hemorrhage, sponsored by Joseph Broderick, MD.
- Active
- Registry status
- Phase 3
- Development phase
- 860
- Enrollment target
- 20
- Study locations
NCT03496883 is a Phase 3 study of Intracerebral Hemorrhage that is active but no longer recruiting, run by Joseph Broderick, MD. The registered enrollment target is 860 participants, below the 1,146-participant average among 29 other Intracerebral Hemorrhage trials with a reported enrollment target (25% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT03496883, a Phase 3 study of Intracerebral Hemorrhage, is active but no longer recruiting, sponsored by Joseph Broderick, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 860 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Recombinant Activated Factor VII (rFVIIa)
Study Locations (20)
California
- Kaiser Permanente Baldwin Park Medical Center - Baldwin Park
- Mills Peninsula Medical Center - Burlingame
- Kaiser Permanente Downey Medical Center - Downey
- Kaiser Permanente Fontana Medical Center - Fontana
- Kaiser Permanente South Bay Medical Center - Harbor City
- UCSD Health La Jolla - La Jolla
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Kaiser Permanente West Los Angeles Medical Center - Los Angeles
- Ronald Reagan UCLA Medical Center - Los Angeles
- UC Irvine Medical Center, - Orange
- Kaiser Permanente Riverside Medical Center - Riverside
- UC Davis Medical Center - Sacramento
- UCSD Medical Center - Hillcrest Hospital - San Diego
- San Francisco General Hospital - San Francisco
Florida
- UF Health Shands Hospital - Gainesville
- Mayo Clinic - Jacksonville
Georgia
- Grady Memorial Hospital - Atlanta
- WellStar Kennestone Hospital - Marietta
Alabama
- University of Alabama Hospital - Birmingham
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 860 participants |
| Start Date | 2021-12-03 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03496883
The ClinicalTrials.gov registry entry for NCT03496883 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 860 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,146-participant average among 29 other Intracerebral Hemorrhage trials with a reported enrollment target (25% lower). The listed sponsor is Joseph Broderick, MD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Intracerebral Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03496883 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03496883 about?
NCT03496883 is a clinical study titled "Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial". The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that...
What is the current status of trial NCT03496883?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 860 participants. The study started on 2021-12-03. Estimated completion is 2028-01-01.
What conditions does trial NCT03496883 study?
This clinical trial studies the following conditions: Intracerebral Hemorrhage.
What interventions are being tested in trial NCT03496883?
The interventions under investigation include: Placebo (BIOLOGICAL), Recombinant Activated Factor VII (rFVIIa) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03496883?
This trial is sponsored by Joseph Broderick, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03496883 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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