A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Emicizumab in Hemophilia A Pediatric Patients With Inhibitors Estudio Fase III para evaluar la Eficacia, Seguridad y Farmacocinética de Emicizumab en pacientes pediatricos con hemofilia A con inhibidores There is no formal hypothesis testing in the study. Efficacy ? To evaluate clinical effect of prophylactic emicizumab on number of bleeds over time (bleed rate) ? To characterize efficacy of up-titrat...

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A Study to Evaluate the Safety and Efficacy of Obinutuzumab, an antibody targeting certain types of immune cells, in Patients with Lupus Nephritis Estudio para evaluar la seguridad y eficacia de obinituzumab, un anticuerpo dirigido a determinado tipo de células inmunes, en pacientes son nefritis lúpica ? To evaluate the efficacy of obinutuzumab compared with placebo in patients with International Society of Nephrology (ISN)/Renal Pathology Society (RPS) Class III or IV Lupus Nephritis (LN) as measur...

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An Efficacy and Safety Study of Crenezumab in Patients with Prodromal to Mild Alzheimer’s Disease Estudio de Eficacia y Seguridad de Crenezumab en pacientes con Enfermedad de Alzheimer de Prodromica a leve To evaluate the efficacy of crenezumab compared with placebo based on change from baseline to Week (W) 105 in global outcomes as assessed by Clinical Dementia Rating-Sum of Boxes (CDR-SB) Evalua...

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A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic RO5534262 versus No Prophylaxis in Hemophilia A Patients with Inhibitors Ensayo clínico Fase III para evaluar la Eficacia, Seguridad y Farmacocinética del RO5534262 profiláctico frente a la no profilaxis en pacientes con hemofilia A con inhibidores To evaluate the efficacy of prophylactic RO5534262 compared with no prophylaxis in patients with hemophilia A with inhibitors Evaluar la eficacia de RO5534262 profiláctico en comparación con la ...

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A Study to Determine Best Tumor Response With Trastuzumab Emtansine in HER2 Overexpressing Solid Tumors. ESTUDIO PARA DETERMINAR LA MEJOR RESPUESTA TUMORAL CON TRASTUZUMAB EMTANSINA EN TUMORES SÓLIDOS QUE SOBREXPRESAN HER2 To evaluate the efficacy of trastuzumab emtansine by best overall response rate (BOR) as determined by the investigator (using response evaluation criteria in solid tumors [RECIST] 1.1). Evaluar...

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A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab in Patients with Hemophilia A Estudio para evaluar la eficacia, seguridad, farmacocinetica y farmacodinamia de Emicizumab en pacientes con Hemofilia A There is no formal hypothesis testing in this study: Expansion phase: Efficacy objectives •To evaluate the efficacy of prophylactic emicizumab in maintaining adequate control of bleeding •To evaluat...

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A Study of the Safety and Tolerability of Pirfenidone (Esbriet) in Combination with Nintedanib (Ofev) in Patients with Idiopathic Pulmonary Fibrosis Estudio sobre la seguridad y tolerabilidad de la Pirfenidona (Esbriet) en combinación con Nintedanib (Ofev) en pacientes con Fibrosis Pulmonar Idiopática Proportion of patients who complete 24 weeks of combination treatment on pirfenidone at a dose of 1602?2403 milligrams/day (mg/d) and nintedanib at a dose of 200?300 mg/d Proporción de pacientes...

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