We're sorry, but this trial is no longer enrolling volunteers.
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
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 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/
- Unknown facility, Salt Lake City, Utah, 84132
- Unknown facility, Saint Louis, Missouri, 63110
- Unknown facility, Atlanta, Georgia, 30322
- Unknown facility, Aachen, 52074