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We're sorry, but this trial is no longer enrolling volunteers.

NC-HEM-15-4 A Phase III Double-Blind, Randomized, Parallel Group, Multicenter Placebo-Controlled Trial to Study the Efficacy and Safety of Caplacizumab in Patients with Acquired Thrombotic Thrombocytopenic Purpura

Description

The study is a phase III, double blind, placebo-controlled, randomized study to evaluate the efficacy and safety of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

  • Adult male or female ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
  • Requires initiation of daily PE treatment and has received 1 PE treatment prior to randomization
  • Others as defined in the protocol

  • Platelet count ≥100×10E9/L.
  • Serum creatinine level >200

Sites

Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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