Clareo Health | Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
Severe or life threatening clinical condition other than TTP that would impair participation in the study
Subjects with malignancies resulting in a life expectation of less than 3 months
Subjects with known or suspected bone marrow carcinosis
Subjects who cannot comply with study protocol requirements and procedures
Known hypersensitivity to the active substance or to excipients of the study drug
Severe liver impairment, corresponding to grade 3 toxicity defined by the CTCAE scale. For the key liver parameters, this is defined as follows:
* bilirubin \> 3 x upper limit of normal (ULN) (needed to differentiate isolated increase in indirect bilirubin due to hemolysis, this was not an exclusion parameter but disease-related)
Severe chronic renal impairment, as defined by glomerular filtration rate \< 30 mL/min
Note that the use of another investigational drug or device within 30 days prior to screening was not allowed. Participation in non-interventional/observational studies and registries during the study period was allowed. Participation in another clinical study was not allowed until the end of the follow-up period or within 30 days after the last study treatment in case of early subject withdrawal from the study. Subjects who had already participated in the current study and had either completed the study per protocol or had discontinued prematurely, were not allowed to be re-included.
