Search Results - "Gallia, G."

Emicizumab Prophylaxis in Patients Who Have Hemophilia A without Inhibitors by Mahlangu, Johnny, Oldenburg, Johannes, Paz-Priel, Ido, Negrier, Claude, Niggli, Markus, Mancuso, M. Elisa, Schmitt, Christophe, Jiménez-Yuste, Victor, Kempton, Christine, Dhalluin, Christophe, Callaghan, Michael U, Bujan, Willem, Shima, Midori, Adamkewicz, Joanne I, Asikanius, Elina, Levy, Gallia G, Kruse-Jarres, Rebecca

“…Emicizumab binds to activated factor IX and factor X, reproducing the bridging function of the missing factor VIII. In a trial of emicizumab prophylaxis,…”
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Emicizumab Prophylaxis in Hemophilia A with Inhibitors by Oldenburg, Johannes, Mahlangu, Johnny N, Kim, Benjamin, Schmitt, Christophe, Callaghan, Michael U, Young, Guy, Santagostino, Elena, Kruse-Jarres, Rebecca, Negrier, Claude, Kessler, Craig, Valente, Nancy, Asikanius, Elina, Levy, Gallia G, Windyga, Jerzy, Shima, Midori

“…Inhibitors develop in many patients with hemophilia who receive recombinant factor VIII. Prophylaxis with emicizumab, an antibody that functionally replaces…”
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A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors by Young, Guy, Liesner, Ri, Chang, Tiffany, Sidonio, Robert, Oldenburg, Johannes, Jiménez-Yuste, Victor, Mahlangu, Johnny, Kruse-Jarres, Rebecca, Wang, Michael, Uguen, Marianne, Doral, Michelle Y., Wright, Lilyan Y., Schmitt, Christophe, Levy, Gallia G., Shima, Midori, Mancuso, Maria Elisa

“…Emicizumab, a bispecific humanized monoclonal antibody, bridges activated factor IX (FIX) and FX to restore the function of missing activated FVIII in…”
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A Pharmacometric Approach to Substitute for a Conventional Dose-Finding Study in Rare Diseases: Example of Phase III Dose Selection for Emicizumab in Hemophilia A by Yoneyama, Koichiro, Schmitt, Christophe, Kotani, Naoki, Levy, Gallia G., Kasai, Ryu, Iida, Satofumi, Shima, Midori, Kawanishi, Takehiko

“…Background Emicizumab (ACE910) is a bispecific antibody mimicking the cofactor function of activated coagulation factor VIII. In phase I–I/II studies,…”
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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…”
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Safety analysis of rFVIIa with emicizumab dosing in congenital hemophilia A with inhibitors: Experience from the HAVEN clinical program by Levy, Gallia G., Asikanius, Elina, Kuebler, Peter, Benchikh El Fegoun, Soraya, Esbjerg, Sille, Seremetis, Stephanie

“…Background Recombinant activated factor VII (rFVIIa; eptacog alfa activated, NovoSeven®, Novo Nordisk A/S) is a bypassing agent used in congenital hemophilia A…”
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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…”
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A Model‐Based Framework to Inform the Dose Selection and Study Design of Emicizumab for Pediatric Patients With Hemophilia A by Yoneyama, Koichiro, Schmitt, Christophe, Chang, Tiffany, Dhalluin, Christophe, Nagami, Sayaka, Petry, Claire, Levy, Gallia G.

“…Emicizumab is a bispecific antibody mimicking the cofactor function of activated coagulation factor VIII to prevent bleeds in patients with hemophilia A. The…”
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Effect of emicizumab prophylaxis on bone and joint health markers in people with haemophilia A without factor VIII inhibitors in the HAVEN 3 study by Kiialainen, Anna, Niggli, Markus, Kempton, Christine L., Castaman, Giancarlo, Chang, Tiffany, Paz‐Priel, Ido, Adamkewicz, Joanne I., Levy, Gallia G.

“…Introduction Emicizumab prophylaxis significantly reduces bleeding events; however, the associated impact on bone/joint health is unknown. Aim To explore the…”
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The effect of emicizumab prophylaxis on long‐term, self‐reported physical health in persons with haemophilia A without factor VIII inhibitors in the HAVEN 3 and HAVEN 4 studies by Skinner, Mark W., Négrier, Claude, Paz‐Priel, Ido, Chebon, Sammy, Jiménez‐Yuste, Victor, Callaghan, Michael U., Lehle, Michaela, Niggli, Markus, Mahlangu, Johnny, Shapiro, Amy, Shima, Midori, Campinha‐Bacote, Avrita, Levy, Gallia G., Oldenburg, Johannes, Mackensen, Sylvia, Pipe, Steven W.

“…Introduction Severe haemophilia A (HA) has a major impact on health‐related quality of life (HRQoL). Aim Assess the impact of emicizumab on HRQoL in persons…”
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Health‐related quality of life and health status in persons with haemophilia A with inhibitors: A prospective, multicentre, non‐interventional study (NIS) by Mahlangu, Johnny, Oldenburg, Johannes, Callaghan, Michael U., Shima, Midori, Mancuso, Maria Elisa, Trask, Peter, Recht, Michael, Garcia, Claudia, Yang, Renchi, Lehle, Michaela, Macharia, Harrison, Asikanius, Elina, Levy, Gallia G., Kruse‐Jarres, Rebecca, von Mackensen, Sylvia

“…Introduction Real‐world data (RWD) on health‐related outcomes in persons with haemophilia A (PwHA) provide insights into patient needs and can guide clinical…”
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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…”
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Mutations in a member of the ADAMTS gene family cause thrombotic thrombocytopenic purpura by Ginsburg, David, Levy, Gallia G, Nichols, William C, Lian, Eric C, Foroud, Tatiana, McClintick, Jeanette N, McGee, Beth M, Yang, Angela Y, Siemieniak, David R, Stark, Kenneth R, Gruppo, Ralph, Sarode, Ravindra, Shurin, Susan B, Chandrasekaran, Visalam, Stabler, Sally P, Sabio, Hernan, Bouhassira, Eric E, Upshaw, Jefferson D, Tsai, Han-Mou

“…Thrombotic thrombocytopenic purpura (TTP) is a life-threatening systemic illness of abrupt onset and unknown cause. Proteolysis of the blood-clotting protein…”
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Bleeding events and safety outcomes in persons with haemophilia A with inhibitors: A prospective, multi‐centre, non‐interventional study by Mahlangu, Johnny, Oldenburg, Johannes, Callaghan, Michael U., Shima, Midori, Santagostino, Elena, Moore, Maggie, Recht, Michael, Garcia, Claudia, Yang, Renchi, Lehle, Michaela, Macharia, Harrison, Asikanius, Elina, Levy, Gallia G., Kruse‐Jarres, Rebecca

“…Introduction Prospectively collected, real‐world data on bleeds, haemophilic treatment and safety outcomes in persons with haemophilia A (PwHA) with factor…”
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ADAMTS13 turns 3 by Levy, Gallia G., Motto, David G., Ginsburg, David

“…It has now been 3 years since the von Willebrand factor (VWF)–cleaving protease implicated in thrombocytopenic purpura (TTP) pathogenesis was identified as…”
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Untreated bleeds in people with hemophilia A in a noninterventional study and intrapatient comparison after initiating emicizumab in HAVEN 1–3 by Callaghan, Michael U., Asikanius, Elina, Lehle, Michaela, Oldenburg, Johannes, Mahlangu, Johnny, Uguen, Marianne, Chebon, Sammy, Kruse‐Jarres, Rebecca, Jiménez‐Yuste, Víctor, Shima, Midori, Trask, Peter, Kempton, Christine L., Kessler, Craig M., Levy, Gallia G., Peyvandi, Flora

“…Bleeding in people with hemophilia A can be life threatening, and intra‐articular bleeds can result in joint damage. Most clinical studies focus on treated…”
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A phase 2 PK/PD study of andexanet alfa for reversal of rivaroxaban and edoxaban anticoagulation in healthy volunteers by Lu, Genmin, Conley, Pamela B., Leeds, Janet M., Karbarz, Mark J., Levy, Gallia G., Mathur, Vandana S., Castillo, Janice, Crowther, Mark, Curnutte, John T.

“…As with any anticoagulant, factor Xa (FXa) inhibitors are associated with a risk of major bleeding. Andexanet alfa is a recombinant modified human FXa lacking…”
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Deferred Radiation Therapy After Debulking of Nonfunctioning Pituitary Macroadenomas: An Appropriate Option by Nicholas, S.E, Salvatori, R, Rigamonti, D, Brem, H, Redmond, K.J, Quinones-Hinojosa, A, Gallia, G, Lim, M, Kleinberg, L.R

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Sialyltransferase ST3Gal-IV Operates as a Dominant Modifier of Hemostasis by Concealing Asialoglycoprotein Receptor Ligands by Ellies, Lesley G., Ditto, David, Levy, Gallia G., Wahrenbrock, Mark, Ginsburg, David, Varki, Ajit, Le, Dzung T., Marth, Jamey D.

“…A number of poorly characterized genetic modifiers contribute to the extensive variability of von Willebrand disease, the most prevalent bleeding disorder in…”
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Evaluation of low-dose limits in 3D-2D rigid registration for surgical guidance by Uneri, A, Wang, A S, Otake, Y, Kleinszig, G, Vogt, S, Khanna, A J, Gallia, G L, Gokaslan, Z L, Siewerdsen, J H

“…An algorithm for intensity-based 3D-2D registration of CT and C-arm fluoroscopy is evaluated for use in surgical guidance, specifically considering the…”
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