A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin Intravenous (Human), Civacir, in Orthotopic Liver Transplant Recipients
End stage liver disease secondary to Hepatitis C virus infection is the most frequent indication for liver transplantation. However, recurrence of the disease is almost universal and is the cause of increased morbidity and mortality. At this time, attempts to treat recurrence have been difficult as the treatment is difficult to tolerate and often ineffective in the post transplant setting. In this study, we hope to learn if treatment with hepatitis C immunoglobulin (Civacir) post-operatively is safe and effective in the prevention of disease recurrence. Participants will be randomized 1:1 to 300mg/kg or control. Participants will be followed out to 6 months with monitoring of hepatic function and HCV levels. Safety data will be collected through medical follow up, examinations and follow up of hepatic function. Statistical analysis will be conducted by the sponsor to determine if the drug (and dose) are effective in preventing recurrent HCV.
Safety and Effectiveness Trial for the Nanostim Leadless Pacemaker
The purpose of this study is to evaluate the safety and effectiveness of the leadless
pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The
Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in
battery and electrodes, for permanent implantation in the right ventricle. As a leadless
pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has
the same operating principles as a conventional pacemaker.
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