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

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 1,095-participant average among 31 other Intracerebral Hemorrhage trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Ordinal distribution with the following steps: 0-2, 3, 4-6

Conditions Studied

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
Joseph Broderick, MD

2 total trials

What NCT07227246 shows while recruiting

NCT07227246 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 1,095-participant average among 31 other Intracerebral Hemorrhage trials with a reported enrollment target (68% lower).

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 names 20 study sites across 5 states, led by 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.

Similar trials for Intracerebral Hemorrhage

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07227246's enrollment target sits among peer trials

350 15th of 31 higher than 17 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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Source: ClinicalTrials.gov NCT07227246, the US trial registry maintained by the National Library of Medicine. NCT07227246 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.