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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: Active Phase 3 study of Intracerebral Hemorrhage, sponsored by Joseph Broderick, MD.
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 1,078-participant average among 31 other Intracerebral Hemorrhage trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Ordinal distribution with the following steps: 0-2, 3, 4-6
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 |
What the registry record for NCT03496883 still lists
NCT03496883 is an interventional study that assigns participants to a tested intervention. The registered 860 participants enrollment target is mid-sized for trials with a published cap, below the 1,078-participant average among 31 other Intracerebral Hemorrhage trials with a reported enrollment target (20% lower).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Where NCT03496883's enrollment target sits among peer trials
860 8th of 31 higher than 24 of 31 other Intracerebral Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intracerebral Hemorrhage 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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