Search Results - "Bienz, Nives Selak"

Bleeding and safety outcomes in persons with haemophilia A without inhibitors: Results from a prospective non‐interventional study in a real‐world setting by Kruse‐Jarres, Rebecca, Oldenburg, Johannes, Santagostino, Elena, Shima, Midori, Kempton, Christine L., Kessler, Craig M., Lehle, Michaela, Chebon, Sammy, Selak Bienz, Nives, Asikanius, Elina, Mahlangu, Johnny

“…Introduction Prospectively collected real‐world data on bleeds, haemophilia treatment and safety in persons with haemophilia A (PwHA) without factor VIII…”
Get full text

Outcomes in children with hemophilia A with inhibitors: Results from a noninterventional study by Oldenburg, Johannes, Shima, Midori, Kruse‐Jarres, Rebecca, Santagostino, Elena, Mahlangu, Johnny, Lehle, Michaela, Selak Bienz, Nives, Chebon, Sammy, Asikanius, Elina, Trask, Peter, Mancuso, Maria Elisa, Jiménez‐Yuste, Victor, Mackensen, Sylvia, Levy, Gallia G.

“…Background Data regarding management of pediatric persons with hemophilia A (PwHA) with factor VIII (FVIII) inhibitors are limited. This prospective…”
Get full text

Efficacy, safety, and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study by Pipe, Steven W, Shima, Midori, Lehle, Michaela, Shapiro, Amy, Chebon, Sammy, Fukutake, Katsuyuki, Key, Nigel S, Portron, Agnès, Schmitt, Christophe, Podolak-Dawidziak, Maria, Selak Bienz, Nives, Hermans, Cedric, Campinha-Bacote, Avrita, Kiialainen, Anna, Peerlinck, Kathelijne, Levy, Gallia G, Jiménez-Yuste, Victor

“…Emicizumab, a subcutaneously administered, humanised, bispecific, monoclonal antibody, is approved to treat people with haemophilia A of all ages with and…”
Get full text

Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies by Callaghan, Michael U., Negrier, Claude, Paz-Priel, Ido, Chang, Tiffany, Chebon, Sammy, Lehle, Michaela, Mahlangu, Johnny, Young, Guy, Kruse-Jarres, Rebecca, Mancuso, Maria Elisa, Niggli, Markus, Howard, Monet, Bienz, Nives Selak, Shima, Midori, Jiménez-Yuste, Victor, Schmitt, Christophe, Asikanius, Elina, Levy, Gallia G., Pipe, Steven W., Oldenburg, Johannes

“…Prophylaxis with emicizumab, a subcutaneously administered bispecific humanized monoclonal antibody, promotes effective hemostasis in persons with hemophilia A…”
Get full text

Real-World Safety of Emicizumab: The First Interim Analysis of the European Haemophilia Safety Surveillance (EUHASS) Database by Shang, Aijing, Selak Bienz, Nives, Gadiraju, Ravi, Chang, Tiffany, Kuebler, Peter

“…Introduction: Long-term data from the HAVEN 1-4 clinical trials reaffirmed the safety and efficacy of emicizumab (HEMLIBRA®) prophylaxis in persons with…”
Get full text

Activation of the AKT pathway and outcomes in patients (pts) treated with or without ipatasertib (ipat) in metastatic castration-resistant prostate cancer (mCRPC): Next-generation sequencing (NGS) data from the phase III IPATential150 trial by Sweeney, Christopher, Chi, Kim N., Bracarda, Sergio, Sternberg, Cora N., Olmos, David, Sandhu, Shahneen, Massard, Christophe, Matsubara, Nobuaki, Nowicka, Malgorzata, Selak Bienz, Nives, Schenkel, Fanny, Chen, Geng, Wongchenko, Matthew J., Garcia, Josep, De Bono, Johann S.

“…5056 Background: Ipat + abiraterone (abi) significantly reduced the risk of radiographic disease progression vs placebo (pbo) + abi in pts with mCRPC and PTEN…”
Get full text

Safety and Efficacy of Emicizumab in Persons with Hemophilia a with or without FVIII Inhibitors: Pooled Data from Four Phase III Studies (HAVEN 1-4) by Callaghan, Michael U., Négrier, Claude, Paz-Priel, Ido, Chang, Tiffany, Chebon, Sammy, Lehle, Michaela, Mahlangu, Johnny, Young, Guy, Kruse-Jarres, Rebecca, Mancuso, Maria Elisa, Niggli, Markus, Kuebler, Peter, Selak Bienz, Nives, Shima, Midori, Jimenez-Yuste, Victor, Schmitt, Christophe, Asikanius, Elina, Levy, Gallia, Pipe, Steven W., Oldenburg, Johannes

“…Introduction: Emicizumab-a subcutaneously administered, bispecific, humanized, monoclonal antibody-promotes effective hemostasis in people with hemophilia A…”
Get full text

Bleeding Events and Safety Outcomes in Pediatric Persons with Hemophilia A with Inhibitors: The First Non-Interventional Study (NIS) from a Real-World Setting by Oldenburg, Johannes, Shima, Midori, Kruse-Jarres, Rebecca, Santagostino, Elena, Mahlangu, Johnny, Selak Bienz, Nives, Chebon, Sammy, Asikanius, Elina, Levy, Gallia G.

“…Introduction Management of persons with hemophilia A (PwHA) with anti-FVIII antibodies (inhibitors) remains an unmet need, particularly in pediatric patients…”
Get full text

Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies by Kruse-Jarres, Rebecca, Peyvandi, Flora, Oldenburg, Johannes, Chang, Tiffany, Chebon, Sammy, Doral, Michelle Y., Croteau, Stacy E., Lambert, Thierry, Kempton, Christine L., Pipe, Steven W., Ko, Richard H., Trzaskoma, Benjamin, Dhalluin, Christophe, Bienz, Nives Selak, Niggli, Markus, Lehle, Michaela, Paz-Priel, Ido, Young, Guy, Jiménez-Yuste, Víctor

“…•This is the largest summary to date of the management of people with hemophilia A on emicizumab prophylaxis undergoing surgery.•Major and minor surgeries were…”
Get full text