ViroPharma says its recently initiated second Phase III clinical study of Camvia in liver transplant patients is now open to patient recruitment.
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The study will evaluate the prophylactic use of Camvia in patients undergoing a liver transplant procedure, and will be conducted in up to 60 US transplant centers. The first Phase III study of Camvia was initiated in September 2006 in patients undergoing a stem cell transplant.
ViroPharma’s study will compare the efficacy, safety and tolerability of prophylactic use of Camvia versus oral ganciclovir when administered for up to 14 weeks for the prevention of cytomegalovirus (CMV) disease in recipients of orthotopic liver transplants at high risk of developing CMV disease. The study also will evaluate the pharmacokinetics of Camvia in this subject population.
“The initiation of this second Phase III study is our latest milestone as we work towards our goal of making this important drug available for the more than 120,000 transplant patients throughout the world who are at risk of deadly CMV disease,” commented Colin Broom, ViroPharma’s chief scientific officer.