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ViroPharma initiates phase II study of C1 Esterase Inhibitor

Friday, April 1, 2011 11:13 AM

Pennsylvania-based ViroPharma announced initiation of a phase II clinical study to evaluate the safety and efficacy of C1 Esterase Inhibitor for the treatment of acute antibody-mediated rejection (AMR) in recipients of donor-specific cross-match positive kidney transplants.

This randomized, double blind, placebo-controlled study will evaluate the safety, tolerability and clinical effect of C1 Esterase Inhibitor for the treatment of acute antibody-mediated rejection in recipients of donor-specific cross-match positive kidney transplants. The study will enroll 20 subjects (10 study drug/10 placebo), and will be conducted at up to four transplant centers in the U.S.  Subjects will be assessed after two weeks of treatment for safety, PK/PD, and clinical effect and again at six months post-transplant for graft function and patient survival.

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