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NCT07227246 · ClinicalTrials.gov registry record · Phase 3

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2

A Phase 3 study of Intracerebral Hemorrhage, sponsored by Joseph Broderick, MD.

Recruiting
Registry status
Phase 3
Development phase
350
Enrollment target
20
Study locations

NCT07227246 is a Phase 3 study of Intracerebral Hemorrhage that is actively recruiting participants, run by Joseph Broderick, MD. The registered enrollment target is 350 participants, below the 1,164-participant average among 29 other Intracerebral Hemorrhage trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT07227246, a Phase 3 study of Intracerebral Hemorrhage, is actively recruiting participants, sponsored by Joseph Broderick, MD.

RECRUITING
Registry status
Phase 3
Development phase
350 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 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign.

Conditions Studied

Intracerebral Hemorrhage

Interventions

  • BIOLOGICAL Recombinant Factor VIIa
  • BIOLOGICAL Biological/Vaccine: Placebo

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

FieldValue
Enrollment Target 350 participants
Start Date 2025-05-06
Est. Completion 2029-06
Phase Phase 3

Sponsor

Joseph Broderick, MD

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07227246

The ClinicalTrials.gov registry entry for NCT07227246 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 350 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,164-participant average among 29 other Intracerebral Hemorrhage trials with a reported enrollment target (70% 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 Recombinant Factor VIIa is the first listed.

NCT07227246 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT07227246 about?

NCT07227246 is a clinical study titled "Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2". 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 NCT07227246?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 350 participants. The study started on 2025-05-06. Estimated completion is 2029-06.

What conditions does trial NCT07227246 study?

This clinical trial studies the following conditions: Intracerebral Hemorrhage.

What interventions are being tested in trial NCT07227246?

The interventions under investigation include: Recombinant Factor VIIa (BIOLOGICAL), Biological/Vaccine: Placebo (BIOLOGICAL).

Who is sponsoring clinical trial NCT07227246?

This trial is sponsored by Joseph Broderick, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07227246 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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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.