IdeS in Asymptomatic Antibody-Mediated Thrombotic Thrombocytopenic Purpura (TTP) Patients

Exclusion Criteria

• •Prior malignancy within 5 years
• •Test positive for serum hepatitis B surface antigen, hepatitis C antibody and human immunodeficiency virus (HIV)
• •Ongoing infectious disease including P-CRP \>10
• •Test positive for IgE antibodies against IdeS
• •Secondary cause of TTP
• •Rituximab treatment or other antibody-based therapy within 7 days prior to IdeS dosing
• •Treatment with investigational medicinal product within the last 12 weeks proceeding screening
• •Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure \> NYHA (New York Heart Association) grade 3, unstable coronary disease or oxygen dependent COPD
• •History of any other clinically significant disease or disorder which may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study
• •Hypogammaglobulinemia defined as any values of P-total IgG less than 3 g/L
• •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to IdeS (e. g. streptokinase and/or staphylokinase)
• •Substance abuse or other concurrent medical condition that could confound study interpretation or affect the patient's ability to tolerate or complete the study
• •Breast feeding women or women with a positive pregnancy test
• •Previously received IdeS treatment