Last updated on December 2019

A Trial of Caplacizumab in Japanese Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)


Brief description of study

Primary Objective:

To evaluate the effect of caplacizumab on prevention of recurrence of aTTP (proportion of participants with a recurrence of aTTP) during the overall study period.

Secondary Objectives:

  • To evaluate effect of caplacizumab on
  • prevention of recurrence of TTP (the number of recurrences of TTP) during overall study period.
  • a composite endpoint consisting of aTTP-related mortality, recurrence of aTTP and major thromboembolic events during study drug treatment
  • restoring platelet counts as a measure of prevention of further microvascular thrombosis
  • refractory disease
  • biomarkers of organ damage: LDH, cardiac troponin I, serum creatinine
  • plasma exchange (PE) parameters (days of PE and volume of plasma used), days in intensive care unit, days in hospital
  • cognitive status of Japanese patients
  • To evaluate safety profile of caplacizumab in Japanese patients
  • To evaluate effect of caplacizumab on pharmacodynamic (PD) markers in Japanese patients
  • To evaluate pharmacokinetic (PK) profile of caplacizumab in Japanese patients
  • To evaluate immunogenicity of caplacizumab in Japanese patients

Detailed Study Description

Study duration per participant is approximately 2 months up to approximately 6 months in case of treatment extension and recurrence during the study drug treatment period.

Clinical Study Identifier: NCT04074187

Find a site near you

Start Over