A Phase IIa, Randomized, Open-label, Proof-of-Concept Study to Evaluate Safety, Tolerability and Efficacy of Ir CPI in Patients with Spontaneous Intracerebral Haemorrhage - the BIRCH study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500491-53-00

Acronym

Clin_IrCPI_201

Enrollment

Registered

2023-02-06

Start date

2023-07-27

Completion date

Unknown

Last updated

2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spontaneous intracerebral haemorrhage

Brief summary

Adverse event/SAE monitoring, ECGs, Vital signs, Physical examinations and neurological evaluations, Biochemistry, haematology, coagulation (aPTT)

Detailed description

Change from baseline in PHO and haemorrhage volumes measured by CT scan, Change from baseline in Ir-CPI plasma concentrations, Change from baseline in aPTT ratio, residual FXI and FXII activities and percentages of inhibition of FXI and FXII procoagulant activities

Interventions

DRUGIXODES RICINUS CONTACT PHASE INHIBITOR

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Adverse event/SAE monitoring, ECGs, Vital signs, Physical examinations and neurological evaluations, Biochemistry, haematology, coagulation (aPTT)	—

Secondary

Measure	Time frame
Change from baseline in PHO and haemorrhage volumes measured by CT scan, Change from baseline in Ir-CPI plasma concentrations, Change from baseline in aPTT ratio, residual FXI and FXII activities and percentages of inhibition of FXI and FXII procoagulant activities	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026