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Journal Articles

Phase 1 Repeat Dosing with BIVV001: The First Investigational Factor VIII Product to Break through the Von Willebrand Factor-Imposed Half-Life Ceiling

Toshko Lissitchkov, Kara Rice, Suresh Katragadda, Annemieke Willemze, Craig Benson, Karin Knobe

Blood (2019) 134 (Supplement_1): 625.

https://doi.org/10.1182/blood-2019-122211

Published: 2019

Journal Articles

Rivaroxaban for Treatment of Pediatric Venous Thromboembolism. an Einstein-Jr Phase 3 Dose-Exposure-Response Evaluation

Guy Young, MD, Anthonie WA. Lensing, MD PhD, Paul Monagle, MBBS, MSc, Christoph Male, MD, Dagmar Kubitza, MD

Blood (2019) 134 (Supplement_1): 164.

https://doi.org/10.1182/blood-2019-124873

Published: 2019

Journal Articles

A Quantitative Systems Pharmacology (QSP) Model to Predict Receptor Occupancy of Bruton's Tyrosine Kinase (BTK) Inhibitors in Peripheral Blood Mononuclear Cells, Bone Marrow and Lymph Nodes of Patients with B-Cell Malignancies

Srikumar Sahasranaman, PhD, Oleg Demin, Jr., Dmitry Shchelokov, Veronika Musatova, Nageshwar Budha, PhD, Ying Ou, PhD

Blood (2019) 134 (Supplement_1): 1289.

https://doi.org/10.1182/blood-2019-129133

Published: 2019

Journal Articles

Exposure-Response Relationship of the SMART-Ig Anti-hC5 Antibody Crovalimab (SKY59): Results from the Umbrella Phase 1/2 Composer Trial in Healthy Volunteers and PNH Patients

Alexandre Sostelly, M.Eng., PhD, Simon Buatois, Antoine Soubret, Erica Winter, PharmD, Barbara Klughammer, PhD, Joy C. Hsu, Gregor Jordan, Christoph Bucher, MD, Jean-Eric Charoin, Keisuke Gotanda, Kenji Shinomiya, Zsolt Nagy, MD PhD, Jens P. Panse, Sung-Soo Yoon, MD PhD, Régis Peffault de Latour, MD PhD, Junichi Nishimura, MD PhD, Alexander Röth, MD PhD

Blood (2019) 134 (Supplement_1): 3745.

https://doi.org/10.1182/blood-2019-124258

Published: 2019

Journal Articles

A Phase 1 Study of ALX148, a CD47 Blocker, in Combination with Rituximab in Patients with Non-Hodgkin Lymphoma

Tae Min Kim, MD PhD, Nehal Lakhani, MD PhD, Justin Gainor, MD, Manali Kamdar, MD MD, Philip Fanning, PhD, Pierre Squifflet, MSc, Feng Jin, PhD, Hong Wan, PhD, Jaume Pons, PhD, Sophia S Randolph, MD PhD, Won Seog Kim, MD PhD

Blood (2019) 134 (Supplement_1): 1953.

https://doi.org/10.1182/blood-2019-123219

Published: 2019

Journal Articles

Consistency of Dosing of Turoctocog Alfa Pegol (N8-GP) throughout the Pathfinder Clinical Trials: Implications for Recommendations for Effective Prophylaxis, Bleed Resolution, and Perioperative Management

Miguel A. Escobar, MD, Allison P. Wheeler, MD, Steven R. Lentz, MD PhD, Wan Hui Ong Clausen, PhD, David Cooper

Blood (2019) 134 (Supplement_1): 3635.

https://doi.org/10.1182/blood-2019-124889

Published: 2019

Journal Articles

Phase 1/2 Study of Tirabrutinib (ONO/GS-4059), a Next-Generation Bruton's Tyrosine Kinase (BTK) Inhibitor, Monotherapy in Patients with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

Motoo Nagane, MD PhD, Yoshitaka Narita, MD PhD, Kazuhiko Mishima, MD PhD, Yasuhito Terui, MD PhD, Yoshiki Arakawa, MD PhD, Hajime Yonezawa, MD PhD, Katsunori Asai, MD PhD, Noriko Fukuhara, MD PhD, Kazuhiko Sugiyama, MD PhD, Naoki Shinojima, MD PhD, Junsaku Kitagawa, Arata Aoi, Ryo Nishikawa, MD PhD

Blood (2019) 134 (Supplement_1): 1586.

https://doi.org/10.1182/blood-2019-123362

Published: 2019

Journal Articles

Severe Bleeding Events in Hemophilia Α Patients Receiving Emicizumab Prophylaxis

Karen L. Zimowski, MD, Glaivy M. Batsuli, MD, Paulette Bryant, MD, Jenny McDaniel, MD, Kelly Tickle, MSN, APN, PPCNP-BC, Shannon L. Meeks, MD, Robert F. Sidonio, Jr., MD MSc

Blood (2019) 134 (Supplement_1): 1126.

https://doi.org/10.1182/blood-2019-126659

Published: 2019

Journal Articles

Pharmacokinetics of Extended Half-Life Factor VIII Products By myPKFiT R Is Useful for Personalized Treatment in Children with Severe Hemophilia a

Risa Matsumura, Keita Tomioka, MD, Shiho Nishimura, MD, Yoko Mizoguchi, MD PhD, Hiroshi Kawaguchi, MD PhD, Masao Kobayashi, MD PhD

Blood (2019) 134 (Supplement_1): 1127.

https://doi.org/10.1182/blood-2019-128149

Published: 2019

Journal Articles

Amelioration of Rigosertib Treatment Related Genitourinary (GU) Adverse Events (AEs) in Patients with Myelodysplastic Syndromes: Implementation of Novel Dosing Regimen Derived through Pharmacokinetic Modeling in Phase 2 Study of Oral Rigosertib in Combination with Azacitidine

David Taft, PhD, Tarang Vora, MS, Chen Ren, PhD, Patrick S. Zbyszewski, MBA, Joseph Morgan, MD, Michael E. Petrone, MD MPH, Steven M. Fruchtman, MD, Manoj Maniar, PhD

Blood (2018) 132 (Supplement 1): 4379.

https://doi.org/10.1182/blood-2018-99-118463

Published: 2018

Journal Articles

Morning Vs Bedtime Aspirin Intake in Patients with Essential Thrombocythemia

Emma Cacciola, MD, Elio Gentini Cacciola, MDcal Student, Veronica Vecchio, MDcal Student, Rossella Rosari Cacciola

Blood (2018) 132 (Supplement 1): 4295.

https://doi.org/10.1182/blood-2018-99-113446

Published: 2018

Journal Articles

BIVV001: The First Investigational Factor VIII Therapy to Break Through the VWF Ceiling in Hemophilia A, with Potential for Extended Protection for One Week or Longer

Barbara A Konkle, Amy Shapiro, Doris Quon, Janice Staber, Takashi Suzuki, MD PhD, Stacey Poloskey, Kara Rice, Suresh Katragadda, Dan Rudin, Joachim Fruebis

Blood (2018) 132 (Supplement 1): 636.

https://doi.org/10.1182/blood-2018-99-113575

Published: 2018

Journal Articles

Real-World Data on the Use of rFIXFc in Subjects With Hemophilia B for Up to 3.7 Years Demonstrates Improved Bleed Control and Adherence With Reduced Treatment Burden

Amy Shapiro, Ateefa Chaudhury, Nisha Jain, Elisa Tsao, Chris Barnowski, Jing Feng, Doris Quon

Blood (2018) 132 (Supplement 1): 2493.

https://doi.org/10.1182/blood-2018-99-116909

Published: 2018

Journal Articles

Dose Selection Process for Younger Children Participating in a Phase 3 Study to Evaluate the Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Patients with Sickle Cell Disease

Brinda Tammara, PhD, Frank E. Shafer, MD, Lutz Harnisch, MD

Blood (2018) 132 (Supplement 1): 3643.

https://doi.org/10.1182/blood-2018-99-117550

Published: 2018

Journal Articles

B-YOND Final Results Confirm Established Safety, Sustained Efficacy, and Extended Dosing Interval for Up to 4 Years of Treatment With rFIXFc in Previously Treated Subjects With Severe Hemophilia B

Margaret Ragni, Roshni Kulkarni, K. John Pasi, MB, ChB, PhD FRCP, FRCPath, FRCPCH, Kathelijn Fischer, Johnny Mahlangu, Amy Shapiro, Beatrice Nolan, Johannes Oldenburg, Tadashi Matsushita, Annemieke Willemze, Huixing Yuan, Dan Rudin

Blood (2018) 132 (Supplement 1): 1214.

https://doi.org/10.1182/blood-2018-99-110100

Published: 2018

Journal Articles

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of the Pharmacokinetics and Pharmacodynamics of REGN3918, a Human Antibody Against Complement Factor C5, in Healthy Volunteers

Jonathan Weyne, MD, Yan Ni, PhD, Richard DelGizzi, PA, MS, Stephen Godin, PhD, Lori Morton, PhD, Srinivasa Prasad, PhD, Andrew J Rankin, PhD, Melissa Simek-Lemos, MPH, ming-Dauh Wang, PhD, Ronda Rippley, PhD, Olivier Harari, MD PhD

Blood (2018) 132 (Supplement 1): 1039.

https://doi.org/10.1182/blood-2018-99-112262

Published: 2018

Journal Articles

Preliminary Safety, Pharmacokinetic, and Pharmacodynamic Results from a Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton's Tyrosine Kinase Inhibitor (BTKi), Vecabrutinib, in B-Lymphoid Malignancies

John N. Allan, MD, William G. Wierda, MD PhD, Krish Patel, MD, Susan M. O'Brien, MD, Anthony R Mato, MD, Matthew S Davids, Richard R. Furman, MD, John M. Pagel, MD PhD, Judith A. Fox, PhD, Renee Ward, MD PhD, Pietro Taverna, PhD, Jennifer R. Brown, MD PhD

Blood (2018) 132 (Supplement 1): 3141.

https://doi.org/10.1182/blood-2018-99-116382

Published: 2018

Journal Articles

ASPIRE Final Results Confirm Established Safety and Sustained Efficacy for Up to 4 Years of Treatment With rFVIIIFc in Previously Treated Subjects With Severe Hemophilia A

Beatrice Nolan, Johnny Mahlangu, Guy Young, Barbara A Konkle, K. John Pasi, MB, ChB, PhD FRCP, FRCPath, FRCPCH, Johannes Oldenburg, MD PhD, Keiji Nogami, MDPhD, Nikola Tripkovic, Huixing Yuan, Dan Rudin

Blood (2018) 132 (Supplement 1): 1192.

https://doi.org/10.1182/blood-2018-99-118586

Published: 2018

Journal Articles

A Prospective Analysis of Breakthrough Hemolysis in 2 Phase 3 Randomized Studies of Ravulizumab (ALXN1210) Versus Eculizumab in Adults with Paroxysmal Nocturnal Hemoglobinuria

Robert A. Brodsky, MD, Regis Peffault De Latour, Scott T. Rottinghaus, MD, Alexander Röth, MD, Antonio M. Risitano, MD PhD, Ilene C. Weitz, MD, Peter Hillmen, MB ChB, PhD FRCP, FRCPath, Jaroslaw P. Maciejewski, Jeffrey Szer, MBBS, Jong-Wook Lee, MD PhD, Austin G. Kulasekararaj, MBBS, MD MRCP, FRCPath, Lori Volles, MD, Andrew I. Damokosh, PhD, Stephan Ortiz, RPh, PhD, Lori Shafner, PhD, Anita Hill, MD PhS, Hubert Schrezenmeier, MD

Blood (2018) 132 (Supplement 1): 2330.

https://doi.org/10.1182/blood-2018-99-110874

Published: 2018

Journal Articles

Pharmacokinetic-Pharmacodynamic Analyses to Provide Rezafungin Prophylaxis Dose Selection for Prevention of Invasive Fungal Infections for Bone Marrow Transplant Patients

Elizabeth A Lakota, PharmD, MS, Shawn Flanagan, PhD, Taylor Sandison, MD, MPH, Janice W Brown, MD, Christopher M Rubino, Pharm.D.

Blood (2018) 132 (Supplement 1): 2071.

https://doi.org/10.1182/blood-2018-99-110300

Published: 2018

NARROW

Phase 1 Repeat Dosing with BIVV001: The First Investigational Factor VIII Product to Break through the Von Willebrand Factor-Imposed Half-Life Ceiling

Rivaroxaban for Treatment of Pediatric Venous Thromboembolism. an Einstein-Jr Phase 3 Dose-Exposure-Response Evaluation

A Quantitative Systems Pharmacology (QSP) Model to Predict Receptor Occupancy of Bruton's Tyrosine Kinase (BTK) Inhibitors in Peripheral Blood Mononuclear Cells, Bone Marrow and Lymph Nodes of Patients with B-Cell Malignancies

Exposure-Response Relationship of the SMART-Ig Anti-hC5 Antibody Crovalimab (SKY59): Results from the Umbrella Phase 1/2 Composer Trial in Healthy Volunteers and PNH Patients

A Phase 1 Study of ALX148, a CD47 Blocker, in Combination with Rituximab in Patients with Non-Hodgkin Lymphoma

Consistency of Dosing of Turoctocog Alfa Pegol (N8-GP) throughout the Pathfinder Clinical Trials: Implications for Recommendations for Effective Prophylaxis, Bleed Resolution, and Perioperative Management

Phase 1/2 Study of Tirabrutinib (ONO/GS-4059), a Next-Generation Bruton's Tyrosine Kinase (BTK) Inhibitor, Monotherapy in Patients with Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

Severe Bleeding Events in Hemophilia Α Patients Receiving Emicizumab Prophylaxis

Pharmacokinetics of Extended Half-Life Factor VIII Products By myPKFiT R Is Useful for Personalized Treatment in Children with Severe Hemophilia a

Amelioration of Rigosertib Treatment Related Genitourinary (GU) Adverse Events (AEs) in Patients with Myelodysplastic Syndromes: Implementation of Novel Dosing Regimen Derived through Pharmacokinetic Modeling in Phase 2 Study of Oral Rigosertib in Combination with Azacitidine

Morning Vs Bedtime Aspirin Intake in Patients with Essential Thrombocythemia

BIVV001: The First Investigational Factor VIII Therapy to Break Through the VWF Ceiling in Hemophilia A, with Potential for Extended Protection for One Week or Longer

Real-World Data on the Use of rFIXFc in Subjects With Hemophilia B for Up to 3.7 Years Demonstrates Improved Bleed Control and Adherence With Reduced Treatment Burden

Dose Selection Process for Younger Children Participating in a Phase 3 Study to Evaluate the Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Patients with Sickle Cell Disease

B-YOND Final Results Confirm Established Safety, Sustained Efficacy, and Extended Dosing Interval for Up to 4 Years of Treatment With rFIXFc in Previously Treated Subjects With Severe Hemophilia B

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of the Pharmacokinetics and Pharmacodynamics of REGN3918, a Human Antibody Against Complement Factor C5, in Healthy Volunteers

Preliminary Safety, Pharmacokinetic, and Pharmacodynamic Results from a Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton's Tyrosine Kinase Inhibitor (BTKi), Vecabrutinib, in B-Lymphoid Malignancies

ASPIRE Final Results Confirm Established Safety and Sustained Efficacy for Up to 4 Years of Treatment With rFVIIIFc in Previously Treated Subjects With Severe Hemophilia A

A Prospective Analysis of Breakthrough Hemolysis in 2 Phase 3 Randomized Studies of Ravulizumab (ALXN1210) Versus Eculizumab in Adults with Paroxysmal Nocturnal Hemoglobinuria

Pharmacokinetic-Pharmacodynamic Analyses to Provide Rezafungin Prophylaxis Dose Selection for Prevention of Invasive Fungal Infections for Bone Marrow Transplant Patients

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American Society of Hematology

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American Society of Hematology

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