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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

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Trial Profile

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

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 30 Apr 2025

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At a glance

  • Drugs Ir-CPI (Primary)
  • Indications Cerebral haemorrhage
  • Focus Adverse reactions; Proof of concept
  • Acronyms BIRCH
  • Sponsors Bioxodes

Most Recent Events

  • 24 Apr 2025 According to the Bioxodes media release, the Data Monitoring Committee (DMC) identified no safety concerns related to changes in ICH volumes, serious adverse events, neurological outcomes, or mortality.
  • 24 Apr 2025 Results presented in the Bioxodes Media Release.
  • 24 Apr 2025 According to the Bioxodes media release, the company will release a second interim report in the second half of 2025, and a final analysis of the study in 2026. The company has stopped recruitment for the trial, as it believes that adding more data would not alter the conclusions based on the available findings.

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