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Portuguese to English: Study Protocol General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Portuguese Hipótese:
Estudos de fase 1 e 2a demonstraram que o MHAA4549A é seguro e bem tolerado até o momento em voluntários saudáveis que foram inoculados
com o vírus da influenza A. Dados do estudo de fase 2a também fornecem evidências que a dose de 3600 mg de MHAA4549A é eficaz na redução
da concentração viral em voluntários saudáveis inoculados com o vírus da influenza A. Estas descobertas, quando combinadas com estudos não
clínicos mostram que o MHAA4549A tem eficácia in vitro e in vivo, um perfil de segurança bem tolerado, e atividade antiviral, dando suporte a mais
desenvolvimentos clínicos do MHAA4549A.
Neste estudo de fase 2b (GV29216), o MHAA4549A está sendo avaliado em combinação com o padrão de tratamento atual (oseltamivir), para
diminuir a gravidade e duração da infecção viral com o vírus da influenza A com o último objetivo de reduzir os sintomas clínicos de infecção quando
comparado ao oseltamivir com placebo. Existem três objetivos primários para este estudo de fase 2b:
• Demonstrar a segurança e eficácia do MHAA4549A em combinação com o oseltamivir em pacientes hospitalizados com influenza A
• Demonstrar uma redução da extensão e duração da carga viral em compartimentos pulmonares superiores e inferiores para compreender as
relações entre FC/farmacodinâmica (FD) e FD/eficácia
• Demonstrar e avaliar os desfechos positivos do estudo em pacientes hospitalizados com influenza A, considerando a falta de precedência para
aprovação em pacientes hospitalizados com infecção por influenza, uma área de necessidade médica não atendida
Este estudo de fase 2b foi desenvolvido para estimar a melhoria nos resultados de uma terapia em combinação de 3600 mg do MHAA4549A com o
oseltamivir versus placebo com oseltamivir. Todos os pacientes irão receber oseltamivir o qual faz parte do padrão de tratamento recomendado.
Além disso, e conforme discutido acima, o MHAA4549A é um anticorpo monoclonal humano que tem, até o momento, mostrado um perfil de
segurança aceitável, um perfil de FC consistente com aquele anticorpo humano IgG1 que desconhece os alvos de hospedeiros endogênicos, e
demonstrou uma atividade antiviral no nível da dose planejada de 3600 mg
Objetivo Primário:
Objetivos de segurança
Os objetivos de segurança deste estudo são os seguintes:
• Avaliar a segurança do MHAA4549A em combinação com o oseltamivir comparado com placebo e oseltamivir em pacientes com influenza A grave,
focando na natureza, frequência, e gravidade dos eventos adversos com gravidade séria e não séria, bem como os efeitos em valores laboratoriais,
sinais vitais, parâmetros de eletrocardiograma (ECG) e anticorpos antiterapêuticos (ATA), ou outros biomarcadores de segurança.
Objetivos de eficácia
Os objetivos primários de eficácia deste estudo são os seguintes:
• Para determinar o tempo de normalização da função respiratória de pacientes dosados com MHAA4549A em combinação com oseltamivir
comparado com pacientes dosados com placebo e oseltamivir
Translation - English Hypothesis:
Phase 1 and 2a studies have shown that to date MHAA4549A has been safe and well tolerated in healthy volunteers who were inoculated with the
influenza A virus. Phase 2a study data has also provided evidence that the dose of 3600 mg of MHAA4549A is effective in reducing viral
concentrations in healthy volunteers inoculated with the influenza A virus. These discoveries, when combined with non-clinical studies, show that the
MHAA4549A has in vitro and in vivo efficacy, a well-tolerated safety profile, and antiviral activity, which supports more clinical developments of
MHAA4549A.
In this phase 2b study (GV29216), MHAA4549A is being evaluated in combination with the standard current treatment (oseltamivir) to lessen the
severity and duration of viral infections from the influenza A virus with the ultimate goal of reducing clinical symptoms of infection when compared to
oseltamivir with placebo. There are three primary objectives for this phase 2b study:
• To demonstrate the safety and efficacy of MHAA4549A in combination with oseltamivir in patients hospitalized with influenza A
• To demonstrate a reduction in the extent and duration of the viral load in upper and lower lung compartments to understand the relationship
between PK/Pharmacodynamics (PD) and PD/effectiveness
• To demonstrate and evaluate the positive outcomes of the study in hospitalized patients with influenza A, considering the lack of precedence for
approval in patients hospitalized with influenza infection, an area of unmet medical need
This phase 2b study was developed to estimate the improvement in the results of a combination therapy of 3600 mg of MHAA4549A with oseltamivir
versus placebo with oseltamivir. All patients will receive oseltamivir, which is part of the recommended standard of treatment.
As discussed above, MHAA4549A is also a human monoclonal antibody that has so far shown an acceptable safety profile, a PK profile consistent with
the human IgG1 antibody that does not recognize endogenic host targets, and has shown antiviral activity at the planned dose level of 3600 mg
Primary Objective:
Safety objectives
The safety objectives of this study are as follows:
• To evaluate the safety of MHAA4549A in combination with oseltamivir compared with placebo and oseltamivir in patients with severe influenza A,
focusing on the nature, frequency, and severity of adverse events with serious and nonserious severity, as well as the effects on laboratory values, vital
signs, electrocardiogram (ECG) parameters and anti-therapeutic antibodies (ATA), or other safety biomarkers.
Efficacy objectives
The primary efficacy objectives of this study are as follows:
• To determine the time to normalization of respiratory function of patients dosed with MHAA4549A in combination with oseltamivir compared
with patients dosed with placebo and oseltamivir
Spanish to English: Informed Consent General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - Spanish Período de reposo farmacológico, exclusivamente para los sujetos que entraron con un tratamiento para reducir los niveles de ácido úrico
Si, de acuerdo con los resultados de las pruebas y procedimientos del período de selección, usted es apto para participar en el estudio, se le pedirá que deje de tomar su(s) medicamento(s) actual(es) para la gota y comience a tomar colchicina, con el fin de evitar un recrudecimiento de la gota, al tiempo que empieza un periodo de lavado de 14 días. Dependiendo de los resultados de la prueba de ácido úrico, podría pedírsele que regrese al centro del estudio para volver a comprobar los valores del ácido úrico.
Si es apto, se le hará una cita para que regrese al centro del estudio para realizar la visita del día -2 y comenzar la estadía de 3 noches.
Sujetos que no se administran un tratamiento para reducir los niveles de ácido úrico
Si, de acuerdo con los resultados de las pruebas y los procedimientos del período de selección, usted es apto para participar en el estudio y actualmente no está usando ningún medicamento para la gota, se le pedirá que comience a tomar colchicina todos los días para prevenir crisis de gota, aproximadamente 5 días antes de presentarse para la visita del día -2. Dependiendo de los resultados de la prueba de ácido úrico, podría pedírsele que regrese al centro del estudio para volver a comprobar los valores del ácido úrico.
Translation - English Pharmacological washout period, exclusively for subjects who entered with a treatment to reduce uric acid levels
If, according to the results from the screening period tests and procedures, you are suitable for participating in the study, you will be asked to stop taking your current medication(s) for gout and begin to take colchicine, in order to avoid a resurgence of gout, at the same time the 14-day washout period begins. Depending on the uric acid test results, you may be asked to return to the study site to re-check your uric acid values.
If you are eligible, an appointment will be made for you to return to the study site for the day -2 visit and begin the 3 night stay.
Subjects who are not administering a treatment to reduce uric acid levels
If, according to the results of the tests and procedures during the screening period, you are eligible to participate in the study and are not currently taking any medication for gout, you will be directed to start taking colchicine daily to prevent gout attacks five days before coming for the day -2 visit. Depending on the uric acid test results, you may be asked to return to the study site to re-check your uric acid values.
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Other - Estudio Internacional Sampere
Experience
Years of experience: 33. Registered at ProZ.com: Dec 2008.
I am a graduate of the University of Washington where I majored in Romance Linguistic, and also where I taught beginning Spanish. My research interests in Romance Linguistics include Spanish and Portuguese morphology and syntax.
I have worked as a medical interpreter for several years, and recently I have shifted gears and started working as a full-time translator in the field of life sciences. Most of my work is dedicated to translating all of the documentation required for conducting a pharmaceutical research protocol, and for all of my projects I use Trados for translating and Xbench for quality control.
I am an active member of the American Translators Association and the Northwest Translators and Interpreters Society.
Keywords: pediatrics, tourism, linguistics, psychology. computers, internet, html
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