Trial Information

Summary: A Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin (rThrombin) in Surgical Hemostasis

(1)The primary objective of this study is to compare the development of anti-rThrombin product antibodies at Day 29 between subjects with and without baseline anti-bovine thrombin product antibodies. 

(2). Secondary objectives are to further define the safety profile of rThrombin and to evaluate safety outcomes in subjects with and without baseline anti bovine thrombin product antibodies. 

Patient Inclusion Criteria: See www.hsc.wvu.edu/mbrcc/ctru/ for additional information.

Patient Exclusion Criteria: See www.hsc.wvu.edu/mbrcc/ctru/ for additional information

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Trial listings updated: June 1, 2008 at 6:45:17 AM