A Phase II, Single-blind, Randomised, Placebo-controlled Trial to Study the Efficacy and Safety of Anti-von Willebrand Factor Nanobody Administered as Adjunctive Treatment to Patients With Acquired Thrombotic Thrombocytopenic Purpura

Trial Profile

A Phase II, Single-blind, Randomised, Placebo-controlled Trial to Study the Efficacy and Safety of Anti-von Willebrand Factor Nanobody Administered as Adjunctive Treatment to Patients With Acquired Thrombotic Thrombocytopenic Purpura

Completed
Phase of Trial: Phase II

Latest Information Update: 29 Jun 2018

At a glance

  • Drugs Caplacizumab (Primary) ; Caplacizumab (Primary)
  • Indications Thrombotic thrombocytopenic purpura
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms TITAN
  • Sponsors Ablynx
  • Most Recent Events

    • 29 Jun 2018 According to a European Medicines Agency media release, The European Commission will review the CHMP recommendation and a final decision on the Marketing Authorisation Application for Cablivi in the European Union is expected in the coming months.
    • 29 Jun 2018 According to a European Medicines Agency media release, based on the data of TITAN study and HERCULES study, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Cablivi (caplacizumab) in Europe for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP).
    • 06 Aug 2017 The trial has been discontinued in Belgium.
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