A Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune Thrombocytopenia
rhTPO
Citopenia+13
+ Enfermedades Autoinmunes
+ Trastornos de la coagulación de la sangre
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de febrero de 2011
Fecha en la que se inscribió al primer participante.The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once daily up to 14 days. The subjects with two consecutive platelet counts above 50×10^9/L in the pre-treatment period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for 12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10^9/L～100 ×10^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up for 4 weeks after maintenance treatment. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Platelet transfusion will be administered to subjects with active bleeding symptoms. Toxicity will be monitored continuously during the entire study. Safety will be assessed by adverse events and laboratory tests.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 120 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 14 a 70 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura). Subject with resistance to or relapse after glucocorticoid in the treatment of ITP, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy. Two consecutive platelet counts (not in the same day) < 30×10^9/L. Subject is willing and able to provide written informed consent. Exclusion Criteria: Pregnancy or breast feeding. Having a medical history of thrombosis. Significant abnormal cardio-pulmonary function. Abnormal liver and kidney function: a serum creatinine concentration≥ 176.8µmol/l (1.5mg/dl); a serum aminotransferase concentration: more than 2.0 times the upper limit of the normal range. a serum bilirubin concentration: more than 2.0 times the upper limit of the normal range. Synchronous tumor. Cannot adopt adequate contraceptive precautions during the course of the study. Any other treatment drugs for ITP are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ). Any other situation that is not suitable for participating in the trial according to the judgment of the investigator .
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Peking Union Medical College Hospital
Beijing, ChinaAbrir Peking Union Medical College Hospital en Google Maps