4 results
The study objectives are to determine the incidence rate of FVIII inhibitors, frequency of adverse events (AEs), and serious adverse events (SAEs) associated with the use of CSL627, to evaluate the PK of 50 IU/kg CSL627, and to evaluate the efficacy…
To evaluate the efficacy of rVIII-SingleChain in the treatment of major andminor bleeding events based on the investigator*s 4-point assessment scale
The objective of the study is to provide clinical evidence proving that the Aperius* PercLID* System is safe and non-inferior to Standalone Decompressive Surgery (decompressive spinal surgery without additional instrumentation/fixation) with regards…
The purpose of the INTIBIA pivotal study is to demonstrate the safety and effectiveness of the INTIBIA System in the intended population through 24 months of follow-up. Data at 12-months will be used to support regulatory approval.The objective of…