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An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Trial Profile

An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 May 2024

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At a glance

  • Drugs Crovalimab (Primary) ; Crovalimab (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Acronyms COMPOSER
  • Sponsors Chugai Pharmaceutical; Roche

    • Most Recent Events

    • 20 May 2024 Planned End Date changed from 10 Jun 2031 to 31 Jan 2026.
    • 20 May 2024 Planned primary completion date changed from 31 Mar 2031 to 31 Jan 2026.
    • 01 Aug 2023 Results assessing long-term outcomes crovalimab in patients with paroxysmal nocturnal haemoglobinuria, published in the European Journal of Haematology.

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