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Journal Articles

Pharmacodynamic Profile of a Recombinant ADAMTS13 (BAX930) in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome (USS))

Marie Scully, Paul Knoebl, MD, Karim Kentouche, Lawrence Rice, MD, Jerzy Windyga, MD, Reinhard Schneppenheim, Johanna A Kremer Hovinga, MD PhD, Michiko Kajiwara, Caterina Maggiore, Jennifer Doralt, Leah Martell, Bruce M. Ewenstein

Blood (2016) 128 (22): 135.

https://doi.org/10.1182/blood.V128.22.135.135

Published: 2016

Journal Articles

Synergistic Effects of a Procoagulant Bispecific Antibody and Rescue Therapies on Thrombin Generation- a Potential Safety Risk

Sabine Knappe, Rudolf Hartmann, Brahm Goldstein, MD, Bruce M. Ewenstein, Leonard Valentino, Friedrich Scheiflinger, PhD

Blood (2016) 128 (22): 4952.

https://doi.org/10.1182/blood.V128.22.4952.4952

Published: 2016

Journal Articles

Pharmacokinetics of a Recombinant Von Willebrand Factor in Patients with Severe Von Willebrand Disease

Margaret V Ragni, Giancarlo Castaman, Joan Cox Gill, Peter Kouides, Miranda Chapman, Arthur Sytkowski, Ortrun Obermann-Slupetzky, Isabella Presch, Sandor Fritsch, Bruce M. Ewenstein

Blood (2015) 126 (23): 2293.

https://doi.org/10.1182/blood.V126.23.2293.2293

Published: 2015

Journal Articles

The Effect of Inhibitory Antibodies on Acute Treatment of Bleeding Episodes with OΒΙ-1, an Antihemophilic Factor VIII (recombinant), Porcine Sequence, in Patients with Acquired Hemophilia Α

Heinrich D. Farin, MD, Aaron Novack, PhD, Min Mo, PhD, Christelle Bourgeois, PhD, Frank M Horling, PhD, Bruce M. Ewenstein, MD PhD

Blood (2014) 124 (21): 2831.

https://doi.org/10.1182/blood.V124.21.2831.2831

Published: 2014

Journal Articles

Recombinant Factor VIII Combined With Recombinant Von Willebrand Factor In Patients With Severe Hemophilia A: A Prospective Clinical Study Of Safety and Pharmacokinetics

Toshko Lissitchkov, Jerzy Windyga, Barbara A. Konkle, Wolfgang Draxler, Miranda Chapman, Wing-Yen Wong, Benny Sørensen, Bruce M. Ewenstein

Blood (2013) 122 (21): 336.

https://doi.org/10.1182/blood.V122.21.336.336

Published: 2013

Journal Articles

Pharmacokinetics and safety of a novel recombinant human von Willebrand factor manufactured with a plasma-free method: a prospective clinical trial

Pier Mannuccio Mannucci, Christine Kempton, Carolyn Millar, Edward Romond, Amy Shapiro, Ingvild Birschmann, Margaret V. Ragni, Joan Cox Gill, Thynn Thynn Yee, Robert Klamroth, Wing-Yen Wong, Miranda Chapman, Werner Engl, Peter L. Turecek, Tobias M. Suiter, Bruce M. Ewenstein

Blood (2013) 122 (5): 648–657.

https://doi.org/10.1182/blood-2013-01-479527

Published: 2013

Includes: Supplemental data

Journal Articles

Biological Explanation of Clinically Observed Elevation of TFPI Plasma Levels After Treatment with TFPI-Antagonistic Aptamer BAX 499

Michael Dockal, PhD, Robert Pachlinger, Rudolf Hartmann, PhD, Sabine Knappe, PhD, Benny Sorensen, Wing Yen Wong, Maureen Conlan, Michael Cecerle, Bruce M. Ewenstein, MD PhD, Hartmut J. Ehrlich, MD, Friedrich Scheiflinger, PhD

Blood (2012) 120 (21): 1104.

https://doi.org/10.1182/blood.V120.21.1104.1104

Published: 2012

Journal Articles

Population pharmacokinetics of recombinant factor VIII: the relationships of pharmacokinetics to age and body weight

Sven Björkman, MyungShin Oh, Gerald Spotts, Phillip Schroth, Sandor Fritsch, Bruce M. Ewenstein, Kathleen Casey, Kathelijn Fischer, Victor S. Blanchette, Peter W. Collins

Blood (2012) 119 (2): 612–618.

https://doi.org/10.1182/blood-2011-07-360594

Published: 2012

Includes: Supplemental data

Journal Articles

Detection of Non Inhibitory Binding Antibodies to Von Willebrand Factor Affecting the Clearance of VWF:Ag in Von Willebrand Disease

Blood (2011) 118 (21): 2275.

https://doi.org/10.1182/blood.V118.21.2275.2275

Published: 2011

Journal Articles

Safety and Efficacy Profile of rAHF-PFM for Immune Tolerance Induction as Assessed In 3 Clinical Trials (PUP ITI, PRE-PAIR, and PAIR).

Gerald Spotts, PhD, Brigitt E. Abbuehl, MD, Huong D. Luu, PharmD, Clara K. Song, PharmD, Jacqueline A. Dyck-Jones, Norma Guzman-Becerra, LieLing Wu, MyungShin Oh, Michael Zoerer, Judith Jill V. Sosa, Darby E. Stephens, Linda J. Yamamoto, MD, Bruce M. Ewenstein, MD, PhD

Blood (2010) 116 (21): 3670.

https://doi.org/10.1182/blood.V116.21.3670.3670

Published: 2010

Journal Articles

Use of a Population Pharmacokinetic Model of ADVATE In Pediatric and Adult Patients with Hemophilia A Permits Limited Blood Sampling for Individual Dose Tailoring.

MyungShin Oh, Sven Björkman, Phillip Schroth, Sandor Fritsch, Peter W Collins, Kathelijn Fischer, Victor S. Blanchette, Kathleen M. Casey, Gerald Spotts, Bruce M. Ewenstein

Blood (2010) 116 (21): 1416.

https://doi.org/10.1182/blood.V116.21.1416.1416

Published: 2010

Journal Articles

Recombinant Human Von Willebrand Factor (rhVWF): First-In-Human Study Evaluating Pharmacokinetics, Demonstrating Safety and Tolerability In Type 3 Von Willebrand Disease

Tobias Suiter, MD, Michael Laffan, DM, FRCP, FRCPath, Pier M. Mannucci, MD, Christine L. Kempton, MD, MSc, Edward H Romond, MD, Amy D. Shapiro, MD, Ingvild Birschmann, MD, PhD, Joan Cox Gill, MD, Margaret V. Ragni, MD, MPH, Peter Turecek, PhD, Bruce M. Ewenstein, MD, PhD, VrWF Study Team Baxter BioScience

Blood (2010) 116 (21): 237.

https://doi.org/10.1182/blood.V116.21.237.237

Published: 2010

Journal Articles

Genetic Factors Associated with Inhibitor Development in Hemophilia A: Initial Results From the Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort.

Jan Astermark, MD, PhD, John Schwarz, MA, Sharyne M. Donfield, PhD, Donna M. DiMichele, MD, Bruce M. Ewenstein, MD, PhD, Edward D. Gomperts, MD, George W. Nelson, PhD, Johannes Oldenburg, MD, PhD, Amy D. Shapiro, MD, Gerald Spotts, PhD, Cheryl A. Winkler, PhD, Erik Berntorp, MD, PhD

Blood (2009) 114 (22): 217.

https://doi.org/10.1182/blood.V114.22.217.217

Published: 2009

Journal Articles

Population Pharmacokinetic Model of ADVATE in Pediatric and Adult Patients with Hemophilia A.

Myungshin Oh, PhD, Sven Björkman, PhD, Phillip Schroth, Sandor Fritsch, PhD, Peter Collins, MD, Kathelijn Fischer, MD, PhD, MSc, Victor S. Blanchette, MD, Kathleen M. Casey, PhD, Gerald Spotts, PhD, Bruce M. Ewenstein, MD, PhD

Blood (2009) 114 (22): 3492.

https://doi.org/10.1182/blood.V114.22.3492.3492

Published: 2009

Journal Articles

ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin- Free Method] Post-Authorization Safety Surveillance (PASS): Safety and Efficacy Following Product Switch in Routine Clinical Practice.

Huong Luu, PharmD, Gerald Spotts, PhD, Hartwig Gajek, MD, Alex Kriukov, Roger Berg, MD, Darby Stephens, Kerry Barker, Bruce M. Ewenstein, MD, PhD

Blood (2008) 112 (11): 3375.

https://doi.org/10.1182/blood.V112.11.3375.3375

Published: 2008

Journal Articles

Effect of Normal Variation in Factor VIII Pharmacokinetics on Prophylactic Dosing Requirements in Severe Classical Hemophilia.

Peter Collins, Kathelijn Fischer, MD, PhD, MSC, Victor S. Blanchette, FRCP, Sven Björkman, Myungshin Oh, Phillip Schroth, Kathleen M. Casey, PhD, Gerald Spotts, PhD, Sandor Fritsch, Bruce M. Ewenstein, MD, PhD

Blood (2008) 112 (11): 1222.

https://doi.org/10.1182/blood.V112.11.1222.1222

Published: 2008

Journal Articles

Internal and External Determinants of Bleeding Patterns on Prophylaxis for Severe Haemophilia A.

Kathelijn Fischer, MD, PhD, Peter Collins, MD, Jan Astermark, MD, Victor S. Blanchette, MD, Sven Bjorkman, PhD, Myungshin Oh, PhD, Phillip Schroth, Sandor Fritsch, PhD, Kathleen M. Casey, PhD, Gerald Spotts, PhD, Bruce M. Ewenstein, MD, PhD

Blood (2007) 110 (11): 1145.

https://doi.org/10.1182/blood.V110.11.1145.1145

Published: 2007

Journal Articles

Clinical Implications of Pharmacokinetic Variables in the Management of Patients with Severe Hemophilia A.

Peter W. Collins, MD, Victor Blanchette, MD, Kathelijn Fischer, MD, Jan Astermark, MD, Phillip Schroth, Sandor Fritsch, PhD, Bruce M. Ewenstein, MD, PhD

Blood (2006) 108 (11): 1041.

https://doi.org/10.1182/blood.V108.11.1041.1041

Published: 2006

Journal Articles

Twelve Month Post Licensure Safety and Efficacy Data of Advate rFVIII PFM.

Edward D. Gomperts, MB, BCh, MD, Bruce M. Ewenstein, MD, PhD, Mary Ellen O’Banion, RN, MSN

Blood (2004) 104 (11): 3090.

https://doi.org/10.1182/blood.V104.11.3090.3090

Published: 2004

Journal Articles

Characterization of the Pharmacokinetics of rFVIII in Young Pre-School Children with Hemophilia, Including an Analysis of the Influence of Age and Body Weight.

Victor Blanchette, MD, Amy D. Shapiro, MD, Raina Liesner, BChir, Fernando Hernandez, MD, Anastassios D. Retzios, PhD, Phillip Schroth, CStat, Sandor Fritsch, Gerald Spotts, PhD, Bruce M. Ewenstein, MD, PhD

Blood (2004) 104 (11): 3084.

https://doi.org/10.1182/blood.V104.11.3084.3084

Published: 2004

NARROW

Pharmacodynamic Profile of a Recombinant ADAMTS13 (BAX930) in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome (USS))

Synergistic Effects of a Procoagulant Bispecific Antibody and Rescue Therapies on Thrombin Generation- a Potential Safety Risk

Pharmacokinetics of a Recombinant Von Willebrand Factor in Patients with Severe Von Willebrand Disease

The Effect of Inhibitory Antibodies on Acute Treatment of Bleeding Episodes with OΒΙ-1, an Antihemophilic Factor VIII (recombinant), Porcine Sequence, in Patients with Acquired Hemophilia Α

Recombinant Factor VIII Combined With Recombinant Von Willebrand Factor In Patients With Severe Hemophilia A: A Prospective Clinical Study Of Safety and Pharmacokinetics

Pharmacokinetics and safety of a novel recombinant human von Willebrand factor manufactured with a plasma-free method: a prospective clinical trial

Biological Explanation of Clinically Observed Elevation of TFPI Plasma Levels After Treatment with TFPI-Antagonistic Aptamer BAX 499

Population pharmacokinetics of recombinant factor VIII: the relationships of pharmacokinetics to age and body weight

Detection of Non Inhibitory Binding Antibodies to Von Willebrand Factor Affecting the Clearance of VWF:Ag in Von Willebrand Disease

Safety and Efficacy Profile of rAHF-PFM for Immune Tolerance Induction as Assessed In 3 Clinical Trials (PUP ITI, PRE-PAIR, and PAIR).

Use of a Population Pharmacokinetic Model of ADVATE In Pediatric and Adult Patients with Hemophilia A Permits Limited Blood Sampling for Individual Dose Tailoring.

Recombinant Human Von Willebrand Factor (rhVWF): First-In-Human Study Evaluating Pharmacokinetics, Demonstrating Safety and Tolerability In Type 3 Von Willebrand Disease

Genetic Factors Associated with Inhibitor Development in Hemophilia A: Initial Results From the Hemophilia Inhibitor Genetics Study (HIGS) Combined Cohort.

Population Pharmacokinetic Model of ADVATE in Pediatric and Adult Patients with Hemophilia A.

ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin- Free Method] Post-Authorization Safety Surveillance (PASS): Safety and Efficacy Following Product Switch in Routine Clinical Practice.

Effect of Normal Variation in Factor VIII Pharmacokinetics on Prophylactic Dosing Requirements in Severe Classical Hemophilia.

Internal and External Determinants of Bleeding Patterns on Prophylaxis for Severe Haemophilia A.

Clinical Implications of Pharmacokinetic Variables in the Management of Patients with Severe Hemophilia A.

Twelve Month Post Licensure Safety and Efficacy Data of Advate rFVIII PFM.

Characterization of the Pharmacokinetics of rFVIII in Young Pre-School Children with Hemophilia, Including an Analysis of the Influence of Age and Body Weight.

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American Society of Hematology

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ASH Publications

American Society of Hematology

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