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Ixodes Ricinus Contact Phase Inhibitor

The BIRCH study is a Phase IIa clinical trial investigating the safety, tolerability, and potential efficacy of Ixodes Ricinus Contact Phase Inhibitor (Ir-CPI) in adult patients with spontaneous intracerebral hemorrhage (ICH). This innovative drug is being tested as a potential treatment for brain bleeding, aiming to improve outcomes for patients with this serious condition.

Table of Contents

What is Ixodes Ricinus Contact Phase Inhibitor (Ir-CPI)?

Ixodes Ricinus Contact Phase Inhibitor, also known as Ir-CPI, is an experimental medication currently being studied for its potential to treat spontaneous brain bleeding[1]. This drug is derived from a protein found in ticks, specifically the Ixodes ricinus species[1]. Ir-CPI is being developed as a solution for infusion, which means it’s a liquid medication designed to be given directly into a patient’s vein[1].

What Medical Conditions Does Ir-CPI Target?

The primary focus of Ir-CPI research is on treating spontaneous intracerebral hemorrhage[1]. This condition is also known by several other terms:

  • Hemorrhagic stroke
  • Intracerebral hemorrhage
  • Intracerebral bleed

All these terms refer to a type of stroke caused by bleeding within the brain tissue[1]. This is a serious medical condition that can lead to severe disability or death if not treated promptly.

How is Ir-CPI Administered?

In the current clinical trial, Ir-CPI is being administered as a single intravenous dose[1]. This means the medication is given directly into a vein, allowing it to circulate quickly throughout the body. The maximum daily dose being studied is 22 mg/kg (milligrams per kilogram of body weight), with a maximum total dose of 38.70 mg/kg over a treatment period of up to 2 days[1].

Current Clinical Trial: The BIRCH Study

Ir-CPI is currently being evaluated in a clinical trial called the BIRCH study[1]. This is a Phase IIa study, which means it’s an early stage of testing in humans to evaluate the drug’s safety, determine a safe dosage range, and identify side effects[1].

The study is designed as a randomized, open-label, proof-of-concept trial. This means:

  • Randomized: Participants are randomly assigned to either receive Ir-CPI or be in the control group.
  • Open-label: Both the researchers and participants know who is receiving the treatment.
  • Proof-of-concept: The study aims to verify that the treatment has the potential to work as intended.

Participants are divided into two groups:

  1. Experimental arm: These participants receive a single intravenous dose of Ir-CPI.
  2. Control arm: These participants do not receive the experimental treatment.

The study is conducted in two phases, with a temporary pause after the first 8 participants to analyze initial results[1].

Who is Eligible for the Clinical Trial?

The study has specific criteria for who can participate. Some key inclusion criteria are:

  • Adults aged 18 or older
  • First-time spontaneous brain bleeding in a specific area of the brain (supratentorial), with a volume between 5 and 60 mL
  • Certain scores on neurological assessments (Glasgow Coma Scale and Modified Rankin Scale)

Some reasons why a person might not be eligible include:

  • History of bleeding disorders
  • Planned anticoagulation reversal treatment
  • Severe bleeding into the ventricles of the brain
  • Active systemic infections
  • Women who could become pregnant
  • Body weight over 120 kg
  • Severe kidney problems
  • Known deficiency in certain blood clotting factors

These criteria help ensure the safety of participants and the reliability of the study results[1].

What are the Objectives of the Study?

The main goal of the BIRCH study is to assess the safety and tolerability of Ir-CPI in patients with intracerebral hemorrhage[1]. Additionally, the researchers aim to:

  • Estimate how effective Ir-CPI is in controlling the growth of the brain bleed
  • Understand how the drug moves through and is processed by the body (pharmacokinetics)
  • Assess how the drug affects the body, particularly the blood clotting system (pharmacodynamics)

Safety Monitoring and Assessments

Throughout the study, participants undergo various tests and examinations to monitor their health and the effects of the treatment. These include:

  • Monitoring for adverse events and serious adverse events
  • Physical examinations and neurological evaluations
  • Blood tests to check general health (biochemistry and hematology)
  • Tests to assess blood clotting (coagulation tests)
  • CT scans to measure changes in the size of the brain bleed
  • Blood tests to measure the concentration of Ir-CPI in the blood
  • Specialized tests to assess how Ir-CPI affects specific blood clotting factors

These assessments help ensure participant safety and provide valuable data about how Ir-CPI works in the human body[1].

Aspect Details
Study Name BIRCH Study (2022-500491-53-00)
Drug Ixodes Ricinus Contact Phase Inhibitor (Ir-CPI)
Condition Spontaneous Intracerebral Hemorrhage
Study Phase Phase IIa
Main Objective Assess safety and tolerability of Ir-CPI
Study Design Randomized, open-label, proof-of-concept
Treatment Groups Experimental (Ir-CPI) and Control (no treatment)
Randomization Ratio 3:1 (Ir-CPI : Control)
Dosage Single intravenous dose, max 22 mg/kg daily, 38.70 mg/kg total
Treatment Duration Up to 2 days
Key Measurements Safety, brain hemorrhage volumes, blood clotting parameters

FAQ

  • What is the main purpose of the BIRCH study? The main purpose of the BIRCH study is to assess the safety and tolerability of Ir-CPI in patients with spontaneous intracerebral hemorrhage (ICH). Additionally, the study aims to gather initial data on the drug's effectiveness in managing brain bleeding and to understand how the body processes the medication.
  • Who can participate in this clinical trial? The trial is open to adult patients (18 years or older) who have experienced their first spontaneous, supratentorial intracerebral hemorrhage with a volume between 5 mL and 60 mL. Participants must have a Glasgow Coma Scale best motor score of at least 5 and a Modified Rankin Scale score of 0-2. However, there are several exclusion criteria, such as a history of bleeding disorders or planned anticoagulation reversal treatment.
  • How is the study designed? The BIRCH study is a randomized, open-label trial. Participants are randomly assigned to either receive Ir-CPI (experimental group) or no treatment (control group) in a 3:1 ratio. The study is conducted in two phases, with a temporary pause after the first 8 participants to analyze initial results before continuing with the second phase.
  • What does the treatment involve? Patients in the experimental group receive a single intravenous dose of Ir-CPI. The maximum daily dose is 22 mg/kg, with a maximum total dose of 38.70 mg/kg. The treatment period lasts up to 2 days. Patients in the control group do not receive the experimental treatment.
  • What are the main outcomes being measured in this study? The primary outcomes focus on safety, including monitoring adverse events, physical examinations, neurological evaluations, and blood tests. Secondary outcomes include changes in brain hemorrhage volumes measured by CT scan, Ir-CPI concentrations in the blood, and various blood clotting parameters. These measurements help researchers understand how well the drug works and how it affects the body.

Ongoing Clinical Trials on Ixodes Ricinus Contact Phase Inhibitor

  • Study on the Safety and Effects of Ixodes ricinus Contact Phase Inhibitor in Adults with Spontaneous Brain Bleeding

    Not recruiting

    2 1 1
    Investigated drugs:
    Belgium

Glossary

  • Intracerebral Hemorrhage (ICH): A type of stroke caused by bleeding within the brain tissue, often leading to brain damage and potentially life-threatening complications.
  • Ixodes Ricinus Contact Phase Inhibitor (Ir-CPI): An experimental drug derived from tick saliva that may help control bleeding in the brain by inhibiting certain blood clotting factors.
  • Phase IIa Clinical Trial: An early stage of clinical research that aims to assess the safety, tolerability, and initial effectiveness of a new drug in a small group of patients with the target condition.
  • Supratentorial: Referring to the upper part of the brain, including the cerebral hemispheres, which is above the tentorium cerebelli (a membrane separating the cerebrum from the cerebellum).
  • Glasgow Coma Scale (GCS): A neurological scale used to assess a person's level of consciousness and severity of brain injury, with the motor score being one component of this assessment.
  • Modified Rankin Scale (mRS): A scale used to measure the degree of disability in patients who have suffered a stroke or other neurological injuries.
  • Perihematomal Edema (PHO): Swelling that occurs around a blood clot (hematoma) in the brain following an intracerebral hemorrhage.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • Activated Partial Thromboplastin Time (aPTT): A blood test that measures how long it takes for blood to clot, used to assess the effect of Ir-CPI on blood clotting in this study.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-ixodes-ricinus-contact-phase-inhibitor-in-adults-with-spontaneous-brain-bleeding/