A Study of Caplacizumab in Patients with Acquired Thrombotic Thrombocytopenic Purpura

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety of caplacizumab treatment in more rapidly curtailing ongoing microvascular thrombosis when administered in addition to standard of care treatment in subjects with an acute episode of acquired thrombotic thrombocytopenic purpura.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

  • Adult male or female ≥ 18 years of age at the time of signing the informed consent form
  • 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 PE treatment prior to randomization
  • Other criteria as defined in the protocol

Exclusion Criteria

  • Platelet count ≥100×10E9/L
  • Serum creatinine level >200 µmol/L in case platelet count is > 30×10E9/L
  • Known other causes of thrombocytopenia
  • Congenital TTP (known at the time of study entry)
  • Pregnancy or breast-feeding
  • Subjects who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown
  • Other criteria as defined in the protocol

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Ronald Go, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20192067

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