| Outcome Measures: |
Primary: Number of major and CRNM bleeding events, CRNM bleeding: Clinically Relevant Non-Major bleeding, Approx. 4 weeks (Before study drug or placebo administration)|Number of major and CRNM bleeding events, Approx. 4 weeks (After study drug or placebo administration) | Secondary: AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC), AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose, Approx. 5 months (Pre-dose to follow up)|aPTT will be measured via the kaolin-trigger method (clotting assay), aPTT: activated Partial Thromboplastin Time, Approx. 6 months (Before study drug or placebo administration to follow up)|Factor XI activity will be assessed with an aPTT-based coagulation test using FXI, FXI: Factor XI, Approx. 6 months (Before study drug or placebo administration to follow up)
|
| Locations: |
California Institute of Renal Research - Chula Vista, Chula Vista, California, 91910, United States|Nova Clinical Research, LLC, Bradenton, Florida, 34209, United States|Research by Design, LLC, Chicago, Illinois, 60643, United States|Renal and Transplant Associates of New England, PC, Springfield, Massachusetts, 01107, United States|CHU de Charleroi Hôpital civil, Lodelinsart, Hainaut, 6042, Belgium|UZ Brussel, Bruxelles - Brussel, 1090, Belgium|UZ Leuven Gasthuisberg, Leuven, 3000, Belgium|CHLO - Hospital Santa Cruz, Carnaxide, Lisboa, 2795-53, Portugal|Pluribus Dialise - Cascais (DaVita), Cascais, Lisboa, 2750-663, Portugal|CHMT - Hospital Rainha Santa Isabel, Torres Novas, Santarém, 2350-754, Portugal|Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, 15706, Spain|Ciutat Sanitària i Universitària de Bellvitge, L'Hospitalet de Llobregat, Barcelona, 08907, Spain|Hospital Reina Sofía, Córdoba, 14004, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Hospital Universitario Dr. Peset, Valencia, 46017, Spain
|
