Results 51 to 60 of about 1,795 (145)

Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non‐Japanese Individuals

The Journal of Clinical Pharmacology, Volume 66, Issue 8, August 2026.
Abstract Evaluation of the pharmacokinetics (PK) of new drugs in Japanese individuals is regularly requested by the Japanese regulatory agency prior to participation in global clinical trials or for bridging approaches for regulatory approval. However, the need for PK assessments in the Japanese population may be less compelling for monoclonal ...
Paridhi Gupta, Ashish Sharma, Bernd Meibohm   +2 more
wiley   +1 more source

Sequential Use of Recombinant Porcine Factor VIII and Early Emicizumab in Acquired Hemophilia A: A Case Series

eJHaem, Volume 7, Issue 4, August 2026.
ABSTRACT Background Acquired hemophilia A (AHA) is a rare autoimmune bleeding disorder requiring prompt hemostatic control and sustained prevention of rebleeding. Recombinant porcine factor VIII (rpFVIII, susoctocog alfa) controls acute bleeding, while emicizumab provides prophylaxis. Real‐world data on their sequential use are limited.
Yusuke Yamada, Takashi Onaka, Kazunori Imada   +2 more
wiley   +1 more source

Spotlight on emicizumab in the management of hemophilia A: patient selection and special considerations

Journal of Blood Medicine, 2019
Koji Yada, Keiji NogamiDepartment of Pediatrics, Nara Medical University, Kashihara, Nara, JapanAbstract: Emicizumab is a factor (F)VIIIa-mimicking bispecific antibody recognizing FIXa and FX molecules.
Yada K, Nogami K
doaj  

Effectiveness and Safety of Prophylactic Low‐Dose Emicizumab in Young Children With Hemophilia A: A Multicenter Retrospective Study

eJHaem, Volume 7, Issue 4, August 2026.
ABSTRACT Background Real‐world data on low‐dose emicizumab in young children with hemophilia A are limited. Methods This multicenter retrospective study included 26 children (median age: 2.2 years) receiving individualized low‐dose emicizumab (2019–2025).
Guichi Zhou, Liya He, Chunyan Wang, Yashuang Deng, Dong Peng, Zhaonan Liu, Sixi Liu, Xiaoying Fu, Ying Wang, Xiaoqin Feng   +9 more
wiley   +1 more source

Emicizumab Prophylaxis in Hemophilia A with Inhibitors

New England Journal of Medicine, 2017
Emicizumab (ACE910) bridges activated factor IX and factor X to restore the function of activated factor VIII, which is deficient in persons with hemophilia A. This phase 3, multicenter trial assessed once-weekly subcutaneous emicizumab prophylaxis in persons with hemophilia A with factor VIII inhibitors.We enrolled participants who were 12 years of ...
Johannes, Oldenburg, Johnny N, Mahlangu, Benjamin, Kim, Christophe, Schmitt, Michael U, Callaghan, Guy, Young, Elena, Santagostino, Rebecca, Kruse-Jarres, Claude, Negrier, Craig, Kessler, Nancy, Valente, Elina, Asikanius, Gallia G, Levy, Jerzy, Windyga, Midori, Shima   +14 more
openaire   +6 more sources

Variables Affecting Periprocedural Haemostatic Response in Patients With Haemophilia: Real‐World Retrospective Study

eJHaem, Volume 7, Issue 4, August 2026.
ABSTRACT Introduction Patients with haemophilia (PWH) undergoing invasive procedures are at increased risk of periprocedural bleeding, and optimal haemostatic response (HR) depends on patient‐ and procedure‐related factors. We aimed to evaluate variables associated with HR in PWH undergoing invasive procedures.
Jose Antonio Sanchez Salas, Eva Soler Espejo, Faustino García Candel, Vanessa Roldán Schilling   +3 more
wiley   +1 more source

Final Analysis of the Phase 1/2 Trial of Valoctocogene Roxaparvovec for Severe Haemophilia A

Haemophilia, Volume 32, Issue 4, Page 974-981, July/August 2026.
ABSTRACT Introduction Valoctocogene roxaparvovec is an adeno‐associated virus vector serotype 5 (AAV5)‐mediated gene therapy for severe haemophilia A (HA). Aim Report the final safety and efficacy results of the phase 1/2 trial of valoctocogene roxaparvovec. Methods An open‐label phase 1/2 trial (NCT02576795) enrolled adult males with severe HA (factor
Priyanka Raheja, Savita Rangarajan, Will Lester, Bella Madan, Glenn F. Pierce, Emily Symington, Carolyn Millar, Dane Osmond, Mingjin Li, Konstantia‐Maria Chavele   +9 more
wiley   +1 more source

Emicizumab utilization, safety, and outcomes in people with severe hemophilia and no inhibitors: 3-year follow-up. A report from the UK Haemophilia Centre Doctors’ Organisation

Research and Practice in Thrombosis and Haemostasis
Background: Emicizumab prophylaxis is restricted to severe hemophilia A in the UK. Treatment choice and safety remain a matter of debate. Objectives: This study was conducted to investigate factors influencing treatment choice, continued use, safety, and
Caroline Wall, Hua Xiang, Ben Palmer, Pratima Chowdary, Peter W. Collins, Richard Gorman, Mary Matthias, Charles Percy, Paul Sartain, Susan Shapiro, David Stephensen, Kate Talks, Charles R.M. Hay   +12 more
doaj   +1 more source

The Swiss Haemophilia Registry–Report From the First 8 Years

Haemophilia, Volume 32, Issue 4, Page 923-932, July/August 2026.
ABSTRACT Introduction Patient registries capture disease related information and provide a valuable source for real‐world data on rare diseases and their management. The Swiss Haemophilia Registry (SHR) was established in 2015 on the basis of a new Swiss federal human research act.
Alessandra Bosch, Lorenzo Alberio, Pierre Fontana, Lukas Graf, Johanna A. Kremer Hovinga, Nicolas von der Weid, Mattia Rizzi, Manuela Albisetti, the Swiss Haemophilia Network   +8 more
wiley   +1 more source

Real‐World Use of Emicizumab in Patients With Acquired Haemophilia A: An Interim Safety Analysis of a Large‐Scale Post‑Marketing Surveillance Study

Haemophilia, Volume 32, Issue 4, Page 933-942, July/August 2026.
ABSTRACT Introduction Acquired haemophilia A (AHA) is a rare autoimmune disorder where the development of autoantibodies to factor (F)VIII neutralise its function, leading to bleeding. Emicizumab has been approved for treating AHA in Japan. Aim This post‐marketing study was performed to primarily examine the use and safety of emicizumab, and indirectly
Midori Shima, Katsuyuki Fukutake, Yoshiyuki Ogawa, Yuta Kamei, Chiaki Sugita, Akinori Yuri, Ryota Kobayashi, Akiko Ioka, Tadashi Matsushita   +8 more
wiley   +1 more source