Pharmacokinetics, safety and efficacy of a recombinant factor IX product, trenonacog alfa in previously treated haemophilia B patients.

Collins, P W; Quon, D V K; Makris, M; Chowdary, P; Kempton, C L; Apte, S J; Ramanan, M V; Hay, C R M; Drobic, B; Hua, Y; Babinchak, T J; Gomperts, E D

Collins, P W; Quon, D V K; Makris, M; Chowdary, P; Kempton, C L; Apte, S J; Ramanan, M V; Hay, C R M; Drobic, B; Hua, Y; Babinchak, T J; Gomperts, E D.

Afiliación

Collins PW; Arthur Bloom Haemophilia Centre, School of Medicine Cardiff University, Cardiff, UK.
Quon DVK; Hemophilia Treatment Center, Orthopaedic Hospital, Los Angeles, CA, USA.
Makris M; Department of Haematology, Royal Hallamshire Hospital, Sheffield, UK.
Chowdary P; Katharine Dormandy Haemophilia Care and Thrombosis Unit, Royal Free Hospital NHS Trust, London, UK.
Kempton CL; Department of Hematology and Medical Oncology, Emory University, Atlanta, GA, USA.
Apte SJ; Sahyadri Specialty Hospital, Pune, India.
Ramanan MV; Jehangir Clinical Development Centre, Jehangir Hospital, Pune, India.
Hay CRM; Manchester Haemophilia Comprehensive Care Centre, Manchester, UK.
Drobic B; Clinical Research, Emergent BioSolutions Canada Inc., Winnipeg, MB, Canada.
Hua Y; Clinical Research, Emergent BioSolutions Canada Inc., Winnipeg, MB, Canada.
Babinchak TJ; Clinical Development and Medical Affairs, Emergent BioSolutions Inc., Berwyn, IL, USA.
Gomperts ED; Consultant for Emergent BioSolutions Inc., Montrose, CO, USA.

Haemophilia ; 24(1): 104-112, 2018 Jan.

Article en En | MEDLINE | ID: mdl-28833808

Asunto(s)

Factor IX/uso terapéutico; Hemofilia B/tratamiento farmacológico; Adolescente; Adulto; Área Bajo la Curva; Inhibidores de Factor de Coagulación Sanguínea/sangre; Relación Dosis-Respuesta a Droga; Método Doble Ciego; Factor IX/efectos adversos; Factor IX/farmacocinética; Semivida; Cefalea/etiología; Hemofilia B/patología; Hemorragia/prevención & control; Humanos; Masculino; Curva ROC; Proteínas Recombinantes/farmacocinética; Proteínas Recombinantes/uso terapéutico; Índice de Severidad de la Enfermedad; Resultado del Tratamiento; Adulto Joven

Palabras clave

IB1001; efficacy; haemophilia B; pharmacokinetics; recombinant factor IX; safety

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Factor IX / Hemofilia B Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies Límite: Adolescent / Adult / Humans / Male Idioma: En Revista: Haemophilia Asunto de la revista: HEMATOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Reino Unido

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