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news.CSL Behring has screened first patient in its recombinant coagulation single-chain factor VIII (rFVIII) trial, part of the AFFINITY clinical trial program.
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The CSL Behring rFVIII, called rVIII-SingleChain, is being studied for the treatment of hemophilia A.
The open-label, multicenter trial examines the crossover safety, efficacy and pharmacokinetics of recombinant coagulation single-chain factor VIII compared with recombinant human antihemophilic factor VIII.
Subjects will receive a single infusion of 50IU/kg of octocog alpha followed by a single infusion of 50IU/kg, in part 1 of the study.
In Parts 2 and 3 of the study, subjects will receive infusions of rVIII-SingleChain to prevent and treat bleeding, at a dose and frequency determined by their study doctor, the company said.
CSL chief scientist Andrew Cuthbertson said the company’s recombinant coagulation single-chain factor VIII molecule is showing strong promise.