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
Brief Summary
The study was a Phase III, double-blind, placebo-controlled, randomized study to evaluate the
efficacy 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 thrombotic thrombocytopenic purpura (aTTP) (initial or recurrent), which included thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
- Required initiation of daily PE treatment and had 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.