6 results
The primary efficacy variable is the change in PV from baseline as assessed by 3 D ultrasonography after 78 weeks of double-blind treatment with OM 20-40 mg daily compared to ATE 50-100 mg daily.Secondary efficacy variables:Change from baseline PV…
Primary:The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects undergoing spine, liver, vascular or soft tissue surgery, when…
The primary objective of this trial is to investigate the safety of Fibrocaps* in subjects undergoing liver resection.The secondary objective of this study is to investigate the effectiveness of Fibrocaps* on time to achieve haemostasis and volume…
1. To characterize the efficacy of topical Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, in surgical subjects when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical2. To…
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