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NC-HEM-11-1: 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

Description

The purpose of this study is to determine whether anti-von Willebrand factor Nanobody is safe and effective as adjunctive treatment in patients with acquired thrombotic thrombocytopenic purpura (TTP). Patients will receive either placebo or anti-von Willebrand factor Nanobody as adjunctive therapy to plasma exchange.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • 18 years of age or older
  • Men or women willing to accept an acceptable contraceptive regimen
  • Patients with clinical diagnosis of TTP
  • Necessitating plasma exchange (one, single PE session prior to randomisation into the study is allowed)
  • Patient accessible to follow-up
  • Obtained, signed and dated informed consent

  • Platelet count greater or equal to 100,000/

Sites

  • Utah

    • Unknown facility, Salt Lake City, Utah, 84132
  • Missouri

    • Unknown facility, Saint Louis, Missouri, 63110
  • Georgia

    • Unknown facility, Atlanta, Georgia, 30322
  • Germany

    • Unknown facility, Aachen, 52074
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