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Study Title Principal Investigator
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.
Completed | Liver Cancer | Multisite
Linda Sher
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