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Published byNicholas Bennett Modified over 5 years ago
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IgG-Fc Fusion Proteins and Immunomodulation: What Does the Science Tell Us?
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Introduction/Overview
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Biology of Immunoglobulin G
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Fc Fused-FVIII: Immunomodulation and Tolerogenics
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rFVIIIFc: Reduced Immunogenicity and Induction of Tolerance in Hemophilia A Mice
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Fc Fusion Proteins and Neonatal Exposure
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Fc Fusion of FVIII and Half-Life Prolongation
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PEGylation of FVIII and Half-Life Prolongation
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PEGylated FVIII: Immunomodulation and Tolerogenics
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rVIII-SingleChain (CSL627) and Half-Life Prolongation
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The Impact of Modified Pharmacokinetics of EHL Agents on Clinical Practice
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Safety/Efficacy Data Supporting the Benefits of EHL Agents in Hem-A
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FVIII Fc Fusion Protein (rFVIIIFc): A-LONG Study Design
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FVIII Activity vs Time Profile for EHL rFVIIIFc and Standard rFVIII: A-LONG
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FVIII Fc Fusion Protein (rFVIIIFc): Kids A-LONG Trial Methods and Results
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Safety and Efficacy of BAY 94-9027: Study Design of PROTECT VIII
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PROTECT VIII Summary Results: Bleeding and Dosing
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Interim Analysis of Pathfinder™3 Trial
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rVIII-SingleChain (CSL627): AFFINITY Study Design
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AFFINITY Results: Treatment Regimens Prior to Study Entry and at Study End
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Case Study 1: Previously Untreated Patient
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Case Study 2: Switching a Previously Treated Patient From Standard rFVIII to EHL rFVIIIFc
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Case Study 2: FVIII Activity in Prophylactically Treated Patient Switched to rFVIIIFc Fusion Protein
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Factors to Consider When Personalizing Prophylaxis
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Case Study 3: Patient With Inhibitors, Rescue ITI With rFVIIIFc
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Case Study 3: Patient With Inhibitors, Rescue ITI With rFVIIIFc (cont’d)
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Application of EHL rFVIII Replacement Agents for ITI
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Summary and Conclusions
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Abbreviations
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Abbreviations (cont)
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