3 results
The primary objective of this study is to evaluate the efficacy of SCH 503034800 mg TID PO in combination with PegIntron 1.5 *g/kg QW SC plus ribavirin (800 - 1400 mg/day) in previously untreated adult chronic hepatitis C (CHC) subjects infected…
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…
Primary Safety Objective : To evaluate one month procedural and device safety of the Tendyne Bioprosthetic Mitral Valve System.Primary Safety Endpoint : Device success and freedom from the following device- or procedure-related serious adverse…