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Study on Eptacog Alfa for Treating Acute Hemorrhagic Stroke in Patients with Brain Bleeding

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as acute hemorrhagic stroke, which occurs when there is sudden bleeding in the brain. The treatment being tested is called recombinant coagulation Factor VIIa, also known by its code name rFVIIa. This treatment is a type of protein that helps the blood to clot, potentially reducing the effects of the bleeding. The trial will compare the effects of rFVIIa with a placebo to see if it can improve recovery after a stroke caused by bleeding in the brain.

The purpose of the study is to determine if administering rFVIIa within two hours of the stroke can lead to better outcomes for patients. Participants in the study will receive either the rFVIIa treatment or a placebo. The study will monitor the participants' recovery over a period of time, using a scale that measures how well they can perform daily activities. This scale is known as the modified Rankin Scale (mRS), which is commonly used to assess the level of disability or dependence after a stroke.

The trial aims to find the best time window and group of patients who might benefit the most from this treatment. The study will track the participants' progress for up to 180 days to see if there are improvements in their condition. The results will help determine if rFVIIa can be an effective treatment for those who experience a stroke due to bleeding in the brain.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Participation begins after meeting specific criteria: age between 18 and 80 years, experiencing a spontaneous bleeding in the brain (intracerebral hemorrhage), and the ability to receive the study medication within 120 minutes of the stroke onset.

    Efforts are made to obtain informed consent according to guidelines specific to the country of participation.

  2. Step 2

    Medication administration

    The study involves the administration of a medication called recombinant Factor VIIa (rFVIIa) or a placebo. The medication is given as a slow injection into a vein.

    The goal is to administer the medication within 2 hours of the stroke onset to potentially improve recovery outcomes.

  3. Step 3

    Monitoring and follow-up

    Participants are monitored for changes in their condition. This includes routine imaging tests like CT scans to assess the volume of bleeding in the brain.

    The primary outcome is measured using a scale that evaluates the level of disability or dependence in daily activities at 180 days after the stroke.

  4. Step 4

    Evaluation of outcomes

    The main focus is on the distribution of scores on the modified Rankin Scale (mRS) at 180 days, which ranges from 0 (no symptoms) to 6 (death).

    Secondary outcomes include additional assessments at 90 and 180 days, such as changes in the volume of bleeding and overall health status using specific health questionnaires.

Who can join the trial?

4 criteria

  • Patients must be between the ages of 18 and 80 years old.
  • Patients must have a condition called **spontaneous intracerebral hemorrhage (ICH)**, which means sudden bleeding inside the brain.
  • Patients must be able to receive the study medication within 120 minutes (2 hours) from the start of the stroke or the last time they were known to be well.
  • Efforts must be made to obtain informed consent according to specific guidelines. In the U.S., this is called **EFIC (exception from Informed Consent)**, and in other countries like Canada, Germany, Spain, the U.K., and Japan, it follows their emergency research consent rules.

Who cannot join the trial?

10 criteria

  • Patients who have had a recent surgery or procedure that could increase the risk of bleeding.
  • Patients with a history of severe allergic reactions to the study medication or similar medications.
  • Patients who are currently taking medications that affect blood clotting, such as blood thinners.
  • Patients with a known bleeding disorder, which means their blood does not clot properly.
  • Patients with severe liver disease, as this can affect how the body processes the medication.
  • Patients who are pregnant or breastfeeding, to avoid any potential risks to the baby.
  • Patients with uncontrolled high blood pressure, as this can increase the risk of complications.
  • Patients who have had a previous stroke caused by bleeding in the brain.
  • Patients with a very low level of consciousness, meaning they are not fully awake or aware.
  • Patients who are unable to have a follow-up visit or assessment after the treatment.
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Investigated drugs

rFVIIa: This medication is used in the trial to treat patients who have experienced a sudden bleeding event in the brain, known as an intracerebral hemorrhage. The goal is to administer this treatment as soon as possible, ideally within two hours of the bleeding starting. The purpose of using this medication is to see if it can improve the patient's recovery and reduce disability by stopping the bleeding quickly.

What is already known about the treatment

Recombinant Factor VIIa (rFVIIa) – This medication is administered intravenously and is currently being studied in clinical trials for its potential use in treating acute hemorrhagic stroke. It is not yet widely adopted in medical practice, as research is ongoing to determine its effectiveness and safety. The main therapeutic indication for rFVIIa is to improve outcomes in patients experiencing spontaneous bleeding in the brain, known as intracerebral hemorrhage. At the molecular level, rFVIIa works by activating the clotting process, helping to stop bleeding by promoting the formation of blood clots. It is classified pharmacologically as a hemostatic agent, which means it is used to control bleeding.

Investigated diseases

Acute Hemorrhagic Stroke – This condition occurs when a blood vessel in the brain bursts, leading to bleeding within the brain tissue. The sudden bleeding can cause damage to brain cells and increase pressure within the skull. Symptoms often appear quickly and may include severe headache, weakness, confusion, or difficulty speaking. As the bleeding progresses, it can lead to more severe neurological impairments. The extent of the damage depends on the location and amount of bleeding. Immediate medical attention is crucial to manage the effects of the stroke.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517383-28-00Protocol codeU1111-1201-0087Estimated enrolment1 000 patientsSponsorUniversity Of Cincinnati College Of Medicine

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