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Journal Articles

Clinical Outcomes over 3 Years of Once-Weekly Efanesoctocog Alfa Treatment in Adults and Adolescents with Severe Hemophilia A: Second Interim Analysis from the Phase 3 XTEND-ed Long-Term Extension Study

Robert Klamroth, Stephanie P'ng, Sophie Susen, Davide Matino, Pratima Chowdary, Angela C Weyand, Toshko Lissitchkov, Young-Shil Park, María Teresa Alvarez-Román, Liqi Feng, Helena Palmborg, Jennifer Dumont, Elena Santagostino, Lara Mamikonian, Keiji Nogami

Blood (2024) 144 (Supplement 1): 717.

https://doi.org/10.1182/blood-2024-204533

Published: 2024

Journal Articles

Efficacy and Safety of Prophylaxis with a Plasma-Derived Von Willebrand Factor/ Factor VIII Concentrate in Previously Treated Patients with Von Willebrand Disease

Robert F. Sidonio, Jr., Ana Boban, Leonid Dubey, Adlette Inati, Csongor Kiss, Toshko Lissitchkov, Dzmitry Novik, Elina Peteva, Ali T. Taher, Margarita Arkadevna Timofeeva, Kateryna V. Vilchevska, Vladimir Vdovin, Sylvia Werner, Sigurd Knaub, Claudia Khayat

Blood (2022) 140 (Supplement 1): 8438–8439.

https://doi.org/10.1182/blood-2022-162358

Published: 2022

Journal Articles

Efanesoctocog Alfa Half-Life and Clearance Are Independent of von Willebrand Factor in Severe Hemophilia A: A Post Hoc Analysis from Phase 1/2a Studies

Janice M. Staber, Toshko Lissitchkov, Barbara A. Konkle, Amy D. Shapiro, Doris V. Quon, Roshni Kulkarni, Melinda Hamilton, Ekta Seth Chhabra, Suresh Katragadda, Arman Altincatal, Annemieke Willemze, Jennifer Dumont, Margaret V. Ragni

Blood (2021) 138 (Supplement 1): 1035.

https://doi.org/10.1182/blood-2021-148534

Published: 2021

Journal Articles

First-in-Human Dose-Finding Study of AAVhu37 Vector-Based Gene Therapy: BAY 2599023 Has Stable and Sustained Expression of FVIII over 2 Years

Steven W Pipe, John P Sheehan, Michiel Coppens, Hermann Eichler, Camila Linardi, Sara Wiegmann, Charles RM Hay, Toshko Lissitchkov

Blood (2021) 138 (Supplement 1): 3971.

https://doi.org/10.1182/blood-2021-148661

Published: 2021

Journal Articles

Long-Term Durability, Safety and Efficacy of Fitusiran Prophylaxis in People with Hemophilia a or B, with or without Inhibitors - Results from the Phase II Study

Steven W. Pipe, MD, John Pasi, MB, ChB, PhD FRCP, FRCPath, FRCPCH, Toshko Lissitchkov, Margaret V. Ragni, MDMPH, Claude Négrier, Qifeng Yu, Stacey Poloskey, Baisong Mei, Shauna R. Andersson

Blood (2020) 136 (Supplement 1): 3–4.

https://doi.org/10.1182/blood-2020-136501

Published: 2020

Journal Articles

Potency-Adjusted Analyses of a Head-to-Head Pharmacokinetic Study of Damoctocog Alfa Pegol (BAY 94-9027) and Efmoroctocog Alfa (rFVIIIFc) in Patients with Severe Hemophilia A

Alexander Solms, Anita Shah, Sara Wiegmann, Maurice Ahsman, Erik Berntorp, Andreas Tiede, MD, Alfonso Iorio, MDPhD, Maria Elisa Mancuso, Tihomir Zhivkov, Toshko Lissitchkov

Blood (2020) 136 (Supplement 1): 24–25.

https://doi.org/10.1182/blood-2020-136586

Published: 2020

Journal Articles

First-in-human Gene Therapy Study of AAVhu37 Capsid Vector Technology in Severe Hemophilia A

Steven Pipe, MD, Michael Becka, Elke Detering, Konstantina Vanevski, Toshko Lissitchkov

Blood (2019) 134 (Supplement_1): 4630.

https://doi.org/10.1182/blood-2019-125764

Published: 2019

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

Fitusiran, an Investigational RNAi Therapeutic Targeting Antithrombin for the Treatment of Hemophilia: Updated Results from a Phase 1 and Phase 1/2 Extension Study in Patients without Inhibitors

Margaret V. Ragni, MD, Pencho Georgiev, Tim Mant, Michael Desmond Creagh, Toshko Lissitchkov, David Bevan, Steve Austin, Charles R Hay, Inga Hegemann, Rashid Kazmi, Pratima Chowdary, Savita Rangarajan, Chang-Heok Soh, Akin Akinc, Angela M. Partisano, Benny Sorenson, K John Pasi

Blood (2016) 128 (22): 2572.

https://doi.org/10.1182/blood.V128.22.2572.2572

Published: 2016

Journal Articles

Fitusiran, an Investigational RNAi Therapeutic Targeting Antithrombin for the Treatment of Hemophilia: Updated Results from a Phase 1 and Phase 1/2 Extension Study in Patients with Inhibitors

K John Pasi, Pencho Georgiev, Tim Mant, Toshko Lissitchkov, Michael Desmond Creagh, David Bevan, Steve Austin, Charles R Hay, Inga Hegemann, Rashid Kazmi, Pratima Chowdary, Margaret V. Ragni, MD, Chang-Heok Soh, Akin Akinc, Angela M. Partisano, Benny Sorenson, Savita Rangarajan

Blood (2016) 128 (22): 1397.

https://doi.org/10.1182/blood.V128.22.1397.1397

Published: 2016

Journal Articles

Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial

Elena Santagostino, Uri Martinowitz, Toshko Lissitchkov, Brigitte Pan-Petesch, Hideji Hanabusa, Johannes Oldenburg, Lisa Boggio, Claude Negrier, Ingrid Pabinger, Mario von Depka Prondzinski, Carmen Altisent, Giancarlo Castaman, Koji Yamamoto, Maria-Teresa Álvarez-Roman, Christine Voigt, Nicole Blackman, Iris Jacobs

Blood (2016) 127 (14): 1761–1769.

https://doi.org/10.1182/blood-2015-09-669234

Published: 2016

Includes: Supplemental data

Journal Articles

Long-Term Use of Coagulation Factor IX (Recombinant) Albumin Fusion Protein (rIX-FP) in Previously Treated Patients with Hemophilia B in the Prolong-9FP Program

Aaron Lubetsky, MD, Uri Martinowitz, MD, Toshko Lissitchkov, MD, Christine Voigt, PhD, Denise Wolko, Iris C. Jacobs, MD, Elena Santagostino, MD PhD

Blood (2015) 126 (23): 1096.

https://doi.org/10.1182/blood.V126.23.1096.1096

Published: 2015

Journal Articles

A Subcutaneously Administered Investigational RNAi Therapeutic (ALN-AT3) Targeting Antithrombin for Treatment of Hemophilia: Interim Weekly and Monthly Dosing Results in Patients with Hemophilia A or B

K John Pasi, Pencho Georgiev, Tim Mant, Michael Desmond Creagh, Toshko Lissitchkov, MD, David Bevan, Steve Austin, Charles R Hay, Brigit Brand, Rashid Kazmi, Pratima Chowdary, Margaret V Ragni, Jihong Chen, Akin Akinc, Benny Sorensen, Savita Rangarajan

Blood (2015) 126 (23): 551.

https://doi.org/10.1182/blood.V126.23.551.551

Published: 2015

Journal Articles

Personalized Prophylaxis with Human-Cl Recombinant FVIII in HA Patients

Robert Klamroth, Toshko Lissitchkov, MD, Luminita Rusen, Olaf Walter, MD MBA, Johann Bichler, PhD, K John Pasi, Andreas Tiede, MD PhD, Sigurd Knaub, PhD

Blood (2015) 126 (23): 547.

https://doi.org/10.1182/blood.V126.23.547.547

Published: 2015

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

The TRUST Trial: Anti-Drug Antibody Formation In a Patient With Hemophilia With Inhibitors After Receiving The Activated Factor VII Product Bay 86-6150

Johnny N. Mahlangu, Pei Lin Koh, Heng Joo Ng, Toshko Lissitchkov, Marion Hardtke, Jens Schroeder

Blood (2013) 122 (21): 573.

https://doi.org/10.1182/blood.V122.21.573.573

Published: 2013

Journal Articles

Efficacy, PK and Safety Results of Clinical Study Of Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) In Previously Treated Patients With Hemophilia B

Aaron Lubetsky, MD MSc, Toshko Lissitchkov, MD, Elena Santagostino, MD, PhD, Gantcho Jotov, MD, Tami Barazani-Brutman, Ph.D, Christine Voigt, Ph.D, Tina Moises, Ph.D, Iris C. Jacobs, MD, Uri Martinowitz, MD

Blood (2013) 122 (21): 1109.

https://doi.org/10.1182/blood.V122.21.1109.1109

Published: 2013

Journal Articles

Pharmacokinetics, Efficacy and Safety of BAX326, a Novel Recombinant Factor IX: A Prospective, Controlled, Multicenter Study in Previously Treated Patients with Severe (FIX Level < 1%) or Moderately Severe (FIX Level ≤ 2%) Hemophilia B.

Jerzy Windyga, MD, PhD, Toshko Lissitchkov, MD, PhD, Oleksandra Stasyshyn, MD, Vasily Mamonov, MD, Luminita Rusen, MD, PhD, José Luis Lamas, MD, Myungshin Oh, PhD, Miranda Chapman, Sandor Fritsch, PhD, Borislava G Pavlova, PhD, Wing Yen Wong, MD, Brigitt E. Abbuehl, MD

Blood (2012) 120 (21): 2222.

https://doi.org/10.1182/blood.V120.21.2222.2222

Published: 2012

Journal Articles

Efficacy, PK and Safety Results of a Phase I/II Clinical Trial of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Previously Treated Patients with Haemophilia B (PROLONG - 9FP)

Uriel Martinowitz, MD, Aaron Lubetsky, MD, Elena Santagostino, MD, PhD, Gantcho Jotov, MD, Jacob Luboshitz, MD, Shadan Lalezari, MD, Tami Barazani-Brutman, Ph.D, Christine Voigt, Ph.D, Tina Moises, Ph.D, Iris C. Jacobs, MD, Toshko Lissitchkov

Blood (2012) 120 (21): 1121.

https://doi.org/10.1182/blood.V120.21.1121.1121

Published: 2012

Journal Articles

Human-Cl Rhfviii Effectively and Safely Prevents Bleeding Episodes in Previously Treated Adult Patients with Severe Haemophilia A

Sigurd Knaub, PhD, Toshko Lissitchkov, MD, PhD, Kingsley Hampton, Mario Von Depka, Savita Rangarajan, MBBS, FRCP, FRCPath, Charles R.M. Hay, MD, FRCP, FRCPath, Edward GD Tuddenham, MBBS, FRCP, FRCPath, PhD, Peter Collins, MD, Katharina Holstein, MD, Angela Huth-Kühne, Ingrid Pabinger, MD, Johannes Oldenburg, MD, Johann Bichler

Blood (2012) 120 (21): 1132.

https://doi.org/10.1182/blood.V120.21.1132.1132

Published: 2012

NARROW

Clinical Outcomes over 3 Years of Once-Weekly Efanesoctocog Alfa Treatment in Adults and Adolescents with Severe Hemophilia A: Second Interim Analysis from the Phase 3 XTEND-ed Long-Term Extension Study

Efficacy and Safety of Prophylaxis with a Plasma-Derived Von Willebrand Factor/ Factor VIII Concentrate in Previously Treated Patients with Von Willebrand Disease

Efanesoctocog Alfa Half-Life and Clearance Are Independent of von Willebrand Factor in Severe Hemophilia A: A Post Hoc Analysis from Phase 1/2a Studies

First-in-Human Dose-Finding Study of AAVhu37 Vector-Based Gene Therapy: BAY 2599023 Has Stable and Sustained Expression of FVIII over 2 Years

Long-Term Durability, Safety and Efficacy of Fitusiran Prophylaxis in People with Hemophilia a or B, with or without Inhibitors - Results from the Phase II Study

Potency-Adjusted Analyses of a Head-to-Head Pharmacokinetic Study of Damoctocog Alfa Pegol (BAY 94-9027) and Efmoroctocog Alfa (rFVIIIFc) in Patients with Severe Hemophilia A

First-in-human Gene Therapy Study of AAVhu37 Capsid Vector Technology in Severe Hemophilia A

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

Fitusiran, an Investigational RNAi Therapeutic Targeting Antithrombin for the Treatment of Hemophilia: Updated Results from a Phase 1 and Phase 1/2 Extension Study in Patients without Inhibitors

Fitusiran, an Investigational RNAi Therapeutic Targeting Antithrombin for the Treatment of Hemophilia: Updated Results from a Phase 1 and Phase 1/2 Extension Study in Patients with Inhibitors

Long-acting recombinant coagulation factor IX albumin fusion protein (rIX-FP) in hemophilia B: results of a phase 3 trial

Long-Term Use of Coagulation Factor IX (Recombinant) Albumin Fusion Protein (rIX-FP) in Previously Treated Patients with Hemophilia B in the Prolong-9FP Program

A Subcutaneously Administered Investigational RNAi Therapeutic (ALN-AT3) Targeting Antithrombin for Treatment of Hemophilia: Interim Weekly and Monthly Dosing Results in Patients with Hemophilia A or B

Personalized Prophylaxis with Human-Cl Recombinant FVIII in HA Patients

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

The TRUST Trial: Anti-Drug Antibody Formation In a Patient With Hemophilia With Inhibitors After Receiving The Activated Factor VII Product Bay 86-6150

Efficacy, PK and Safety Results of Clinical Study Of Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) In Previously Treated Patients With Hemophilia B

Pharmacokinetics, Efficacy and Safety of BAX326, a Novel Recombinant Factor IX: A Prospective, Controlled, Multicenter Study in Previously Treated Patients with Severe (FIX Level < 1%) or Moderately Severe (FIX Level ≤ 2%) Hemophilia B.

Efficacy, PK and Safety Results of a Phase I/II Clinical Trial of Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Previously Treated Patients with Haemophilia B (PROLONG - 9FP)

Human-Cl Rhfviii Effectively and Safely Prevents Bleeding Episodes in Previously Treated Adult Patients with Severe Haemophilia A

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American Society of Hematology

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