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16 results on '"Ayguasanosa Jaume"'

1. Efficacy and safety of the neonatal Fc receptor inhibitor efgartigimod in adults with primary immune thrombocytopenia (ADVANCE IV): a multicentre, randomised, placebo-controlled, phase 3 trial

Author

Fillitz, Michael, Knoebl, Paul, Meers, Stef, Amine, Ismail Mohamad, Gumulec, Jaromir, Hlusi, Antonin, Mayer, Jiri, Quittet, Philippe, Viallard, Jean-Francois, Betaneli, Magdana, Datikashvili-David, Irine, Iosava, Genadi, Makhaldiani, Levan, Rejto, Laszlo, Sharashenidze, Nino, Groepper, Stefanie, Röth, Alexander, Hamed, Aryan, Illes, Arpad, Carpenedo, Monica, Artoni, Andrea, Bocchia, Monica, Gamberi, Barbara, Borchiellini, Alessandra, Oliva, Esther Natalie, Patriarca, Andrea, Tomassetti, Simona, Miyakawa, Yoshitaka, Ando, Kiyoshi, Handa, Hiroshi, Katsutani, Shinya, Nishiwaki, Kaichi, Ito, Shoko, Ito, Tomoki, de Boer, Fransien, Jansen, A.J. Gerard, Ciepluch, Hanna, Fornagiel, Szymon, Grosicki, Sebastian, Soroka-Wojtaszko, Maria, Trelinski, Jacek, Bakirov, Bulat, Borisenkova, Elena, Volodicheva, Elena, Shatokhin, Yuri, Proydakov, Andrey, Alonso, Maria Aranzazu, Mingot-Castellano, María Eva, Sanchez-Gonzalez, Blanca, Valcarcel Ferreiras, David, Ayli, Meltem, Hacibekiroglu, Tuba, Demir, Ahmet Muzaffer, Nalçaci, Meliha, Sonmez, Mehmet, Tombak, Anil, Toprak, Selami Kocak, Turgut, Burhan, Vural, Filiz, Yagci, Munci, Altuntas, Fevzi, Turgut, Mehmet, Kaya, Emin, Romanyuk, Nataliya, McDonald, Vickie, Kazmi, Syed Rashid Saeed, Broome, Catherine, Cataland, Spero, Doshi, Ketan, Lentz, Steven R., Boxer, Michael, Rosenberg, Richard, Broome, Catherine M, Kuter, David J, Al-Samkari, Hanny, Bussel, James B, Godar, Marie, Ayguasanosa, Jaume, De Beuf, Kristof, Rodeghiero, Francesco, Michel, Marc, and Newland, Adrian

Published
2023
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4. Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery

Author

Anderson, Christopher D., Labow, Daniel, Fishbein, Thomas, Sheiner, Patricia, Lockstadt, Harry, Courtney, Kecia, Cheng, Junliang, Barrera, Gladis, Henriquez, Waleska T., Minkowitz, Harold, Navarro-Puerto, Jordi, Lakshman, Shankar, Singla, Sonia, Cousar, Charles, Kim, Robin, Villavicencio, Alan, Kirksey, Levester, and Ayguasanosa, Jaume

Published
2019
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6. Efficacy and safety of the neonatal Fc receptor inhibitor efgartigimod in adults with primary immune thrombocytopenia (ADVANCE IV): a multicentre, randomised, placebo-controlled, phase 3 trial

Author

Broome, Catherine M, primary, McDonald, Vickie, additional, Miyakawa, Yoshitaka, additional, Carpenedo, Monica, additional, Kuter, David J, additional, Al-Samkari, Hanny, additional, Bussel, James B, additional, Godar, Marie, additional, Ayguasanosa, Jaume, additional, De Beuf, Kristof, additional, Rodeghiero, Francesco, additional, Michel, Marc, additional, Newland, Adrian, additional, Fillitz, Michael, additional, Knoebl, Paul, additional, Meers, Stef, additional, Amine, Ismail Mohamad, additional, Gumulec, Jaromir, additional, Hlusi, Antonin, additional, Mayer, Jiri, additional, Quittet, Philippe, additional, Viallard, Jean-Francois, additional, Betaneli, Magdana, additional, Datikashvili-David, Irine, additional, Iosava, Genadi, additional, Makhaldiani, Levan, additional, Rejto, Laszlo, additional, Sharashenidze, Nino, additional, Groepper, Stefanie, additional, Röth, Alexander, additional, Hamed, Aryan, additional, Illes, Arpad, additional, Artoni, Andrea, additional, Bocchia, Monica, additional, Gamberi, Barbara, additional, Borchiellini, Alessandra, additional, Oliva, Esther Natalie, additional, Patriarca, Andrea, additional, Tomassetti, Simona, additional, Ando, Kiyoshi, additional, Handa, Hiroshi, additional, Katsutani, Shinya, additional, Nishiwaki, Kaichi, additional, Ito, Shoko, additional, Ito, Tomoki, additional, de Boer, Fransien, additional, Jansen, A.J. Gerard, additional, Ciepluch, Hanna, additional, Fornagiel, Szymon, additional, Grosicki, Sebastian, additional, Soroka-Wojtaszko, Maria, additional, Trelinski, Jacek, additional, Bakirov, Bulat, additional, Borisenkova, Elena, additional, Volodicheva, Elena, additional, Shatokhin, Yuri, additional, Proydakov, Andrey, additional, Alonso, Maria Aranzazu, additional, Mingot-Castellano, María Eva, additional, Sanchez-Gonzalez, Blanca, additional, Valcarcel Ferreiras, David, additional, Ayli, Meltem, additional, Hacibekiroglu, Tuba, additional, Demir, Ahmet Muzaffer, additional, Nalçaci, Meliha, additional, Sonmez, Mehmet, additional, Tombak, Anil, additional, Toprak, Selami Kocak, additional, Turgut, Burhan, additional, Vural, Filiz, additional, Yagci, Munci, additional, Altuntas, Fevzi, additional, Turgut, Mehmet, additional, Kaya, Emin, additional, Romanyuk, Nataliya, additional, Kazmi, Syed Rashid Saeed, additional, Broome, Catherine, additional, Cataland, Spero, additional, Doshi, Ketan, additional, Lentz, Steven R., additional, Boxer, Michael, additional, and Rosenberg, Richard, additional

Published
2023
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8. Efficacy and Safety of Intravenous Efgartigimod in Adults with Primary Immune Thrombocytopenia: Results of a Phase 3, Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial (ADVANCE IV)

Author

Broome, Catherine M., primary, McDonald, Vickie, additional, Miyakawa, Yoshitaka, additional, Carpenedo, Monica, additional, Kuter, David J., additional, Al-Samkari, Hanny, additional, Bussel, James B., additional, Godar, Marie, additional, Ayguasanosa, Jaume, additional, De Beuf, Kristof, additional, Rodeghiero, Francesco, additional, Michel, Marc, additional, and Newland, Adrian C., additional

Published
2022
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9. Time to Achieve Platelet Count Response after Intravenous Efgartigimod in Adults with Primary Immune Thrombocytopenia: A Phase 3, Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial (ADVANCE IV)

Author

Broome, Catherine M., McDonald, Vickie, Miyakawa, Yoshitaka, Carpenedo, Monica, Kuter, David J, Al-Samkari, Hanny, Bussel, James B., Hultberg, Anna, Matthijssens, Filip, Ayguasanosa, Jaume, De Beuf, Kristof, Rodeghiero, Francesco, Michel, Marc, and Newland, Adrian

Published
2023
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10. Efficacy and Safety of Intravenous Efgartigimod 10 Mg/Kg in Adult Patients with Primary Immune Thrombocytopenia: Advance, a Phase 3 Clinical Trial in Progress

Author

Newland, Adrian C., primary, Liebman, Howard A., additional, McDonald, Vickie, additional, Michel, Marc, additional, Miyakawa, Yoshitaka, additional, Parys, Wim, additional, De Haard, Hans, additional, Ulrichts, Peter, additional, Godar, Marie, additional, De Beuf, Kristof, additional, Ayguasanosa, Jaume, additional, Broome, Catherine M, additional, and Kuter, David J., additional

Published
2020
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11. A Prospective, Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections

Author

Bjelović Miloš, Ayguasanosa Jaume, Kim Robin D, Stojanović Miroslav, Vereczkei Andras, Nikolić Srdjan, Winslow Emily, Emre Sukru, Xiao Gary, Navarro-Puerto Jordi, Courtney Kecia, Barrera Gladis, and On behalf of the investigators of the Fibrin Sealant Grifols in Hepatic Resection Clinical Investigation Study Group

Subjects
Fibrin sealant, Liver resection, Local hemostasis, Oxidized cellulose, Parenchymous surgery
Abstract

Background Local hemostatic agents have a role in limiting bleeding complications associated with liver resection. Methods In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (T4) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points T2, T3, T5, T7, and T10. Results The rate of hemostasis by T4 was 92.8% in the FS Grifols group (n = 163) and 80.5% in the Surgicel® group (n = 162) (p = 0.01). The mean TTH was significantly shorter (p < 0.001) in the FS Grifols group (2.8 ± 0.14 vs. 3.8 ± 0.24 min). The rate of hemostasis by T2, T5, and T7 was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%). Conclusions FS Grifols was safe and well-tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.

Published
2018

12. Prospective, Randomized, Phase II, Non-Inferiority Study to Evaluate the Safety and Efficacy of Topical Thrombin (Human) Grifols as Adjunct to Hemostasis During Vascular, Hepatic, Soft Tissue, and Spinal Open Surgery

Author

Minkowitz, Harold, primary, Navarro-Puerto, Jordi, additional, Lakshman, Shankar, additional, Singla, Sonia, additional, Cousar, Charles, additional, Kim, Robin, additional, Villavicencio, Alan, additional, Kirksey, Levester, additional, Ayguasanosa, Jaume, additional, Anderson, Christopher D., additional, Labow, Daniel, additional, Fishbein, Thomas, additional, Sheiner, Patricia, additional, Lockstadt, Harry, additional, Courtney, Kecia, additional, Cheng, Junliang, additional, Barrera, Gladis, additional, and Henriquez, Waleska T., additional

Published
2019
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13. A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery

Author

Nenezić, Dragoslav, primary, Ayguasanosa, Jaume, additional, Menyhei, Gábor, additional, Tamás, Holjencsik, additional, Mátyás, Lajos, additional, Muluk, Satish, additional, Courtney, Kecia, additional, Ibáñez, Julia, additional, Chen, Junliang, additional, Segura-Vasi, Alvaro, additional, Sokurenko, German, additional, Paramesh, Anil, additional, Minkowitz, Harold, additional, Sonkin, Igor, additional, Lal, Brajesh, additional, Ihnat, Daniel, additional, Brooke, Benjamin, additional, Popović, Vladan, additional, Eslami, Mohammad, additional, Farber, Alik, additional, Saha, Sibu, additional, Greenstein, Stuart, additional, Karpenko, Andrey, additional, Katelnitskiy, Ivan, additional, Tran, Nam, additional, Hoch, John, additional, Amin, Ali, additional, White, Paul, additional, Rajani, Ravi R., additional, Griffin, Joseph, additional, Yurvati, Albert, additional, Matsuura, John, additional, Navarro-Puerto, Jordi, additional, Barrera, Gladis, additional, Hames, Carrie, additional, Lloyd, Valerie, additional, Zhang, Yanmei, additional, Lin, Jiang, additional, Li, Henry, additional, Covington, Deborah, additional, Henriquez, Waleska, additional, Soucheiron, Carmen, additional, Beck, Susan, additional, and Casamiquela, Romà, additional

Published
2019
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14. Safety and efficacy of intravenous immunoglobulin (Flebogamma® 10% DIF) in patients with immune thrombocytopenic purpura

Author

Apte, Shashikant, primary, Navarro-Puerto, Jordi, additional, Damodar, Sharat, additional, Ramanan, Vijay, additional, John, Joseph, additional, Kato, Giraldo, additional, Ross, Cecil, additional, Shah, Chirag, additional, Torres, Marcela, additional, Fu, Chieh-Lin ‘Kathy’, additional, Rucker, Karen, additional, Pinciaro, Paul, additional, Barrera, Gladis, additional, Aragonés, Maria Esperança, additional, and Ayguasanosa, Jaume, additional

Published
2019
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15. A Phase 3 Multicenter, Prospective, Open-Label Efficacy and Safety Study of Immune Globulin (Human) 10% Caprylate/Chromatography Purified in Patients with Myasthenia Gravis Exacerbations

Author

Karelis, Guntis, primary, Balasa, Rodica, additional, De Bleecker, Jan L., additional, Stuchevskaya, Tima, additional, Villa, Andres, additional, Van Damme, Philip, additional, Lagrange, Emmeline, additional, Heckmann, Jeannine M., additional, Nicolle, Michael, additional, Vilciu, Crisandra, additional, Bril, Vera, additional, Mondou, Elsa, additional, Griffin, Rhonda, additional, Chen, Junliang, additional, Henriquez, Waleska, additional, Garcia, Beatriz, additional, Camprubi, Sandra, additional, and Ayguasanosa, Jaume, additional

Published
2019
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16. Safety and efficacy of intravenous immunoglobulin (Flebogamma ® 10% DIF) in patients with immune thrombocytopenic purpura.

Author

Apte S, Navarro-Puerto J, Damodar S, Ramanan V, John J, Kato G, Ross C, Shah C, Torres M, Fu C', Rucker K, Pinciaro P, Barrera G, Aragonés ME, and Ayguasanosa J

Subjects
Adolescent, Adult, Aged, Child, Child, Preschool, Female, Humans, Leukocyte Count, Male, Middle Aged, Treatment Outcome, Young Adult, Blood Platelets pathology, Immunoglobulins, Intravenous therapeutic use, Purpura, Thrombocytopenic, Idiopathic drug therapy
Abstract

Aim: To evaluate the safety and efficacy of 10% intravenous immunoglobulin (IVIG; Flebogamma ®  10% DIF) in individuals with chronic immune thrombocytopenic purpura (ITP)., Patients & Methods: Patients aged 3-70 years, diagnosed with chronic ITP, received 1 g/kg IVIG over two consecutive days., Results: 64 evaluable patients (51 adults, 13 children) with chronic ITP received IVIG. The primary efficacy end point (increased platelet counts from ≤20 × 10 9 /l to ≥50 × 10 9 /l by day 8) was achieved by 81.3% of patients; mean time to response was 1.7 days (all responders). Adverse events, mostly mild or moderate, were reported in 59 patients (92.2%)., Conclusion: Flebogamma ®  10% DIF administered over two consecutive days was safe and effective in adults and children with chronic ITP.

Published
2019
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