A Phase II, Single-blind, Randomized, 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
Brief Summary
This study was a Phase II, single-blind, randomized, placebo-controlled trial to determine
whether anti-vWF Nanobody is safe and effective as adjunctive treatment in patients with
aTTP.
Patients received either placebo or anti-vWF Nanobody as adjunctive therapy to plasma
exchange (PE).
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 (adults) or aged 12 to < 18 years (adolescents)
- Male or female subject, willing to accept an acceptable contraceptive regimen
- Subject with a clinical diagnosis of TTP
- Requiring PE (one single PE session prior to randomization into the study was allowed)
- Subject accessible to follow-up
- Subject able to provide signed and dated informed consent and assent (if applicable, for adolescents)
- Platelet count ≥ 100,000/
Sites
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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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