A study to evaluate the safety, tolerability and the effects of Ixodes ricinus-Contact Phase Inhibitor (Ir-CPI) in adult patients with spontaneous intracerebral haemorrhage - the BIRCH study

Phase 1

Recruiting

• Conditions: Spontaneous intracerebral haemorrhage; MedDRA version: 21.1Level: LLTClassification code: 10022754Term: Intracerebral hemorrhage Class: 10029205; MedDRA version: 21.1Level: LLTClassification code: 10022753Term: Intracerebral haemorrhage Class: 10029205; MedDRA version: 20.1Level: LLTClassification code: 10055815Term: Haemorrhage intracerebral Class: 10029205; MedDRA version: 21.1Level: LLTClassification code: 10048863Term: Hemorrhagic stroke Class: 10029205; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 21.1Level: LLTClassification code: 10022751Term: Intracerebral bleed Class: 10029205; MedDRA version: 20.1Level: LLTClassification code: 10019551Term: Hemorrhage intracerebral Class: 10029205

• Registration Number: CTIS2022-500491-53-00
• Lead Sponsor: Bioxodes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-08
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Male or female patients aged = 18 years, written informed consent obtained, First-ever, spontaneous, supratentorial ICH with a volume = 5 mL but = 60 mL, Glasgow Coma Scale (GCS) best motor score no less than 5, Modified Rankin Scale (mRS) score 0-2

Exclusion Criteria

History of bleeding disorders, Planned anticoagulation reversal treatment, Patient with IVH having a Graeb score >3 on initial presentation, use of immunosuppressive or immune modulating therapy at admission, Patients with active systemic infections, Women of childbearing potential, body weight > 120 kg, severe renal impairement, Known deficiency in FXII or haemophilia, Infratentorial ICH, Secondary ICH, Planned neurosurgical hematoma evacuation or other urgent surgical intervention on intial presentation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and tolerability profile of Ir-CPI in ICH patients;Secondary Objective: to obtain the first efficacy estimate of Ir-CPI on evolution of PHO and haemorrhage volumes, to evaluate the pharmacokinetics of Ir-CPI in ICH patients, to assess the pharmacodynamics of Ir-CPI in ICH patients;Primary end point(s): Adverse event/SAE monitoring, ECGs, Vital signs, Physical examinations and neurological evaluations, Biochemistry, haematology, coagulation (aPTT)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Change from baseline in PHO and haemorrhage volumes measured by CT scan;Secondary end point(s):Change from baseline in Ir-CPI plasma concentrations;Secondary end point(s):Change from baseline in aPTT ratio, residual FXI and FXII activities and percentages of inhibition of FXI and FXII procoagulant activities