VORICONAZOLE IN PATIENTS WITH HEMATOLOGIC MALIGNANCIES

本研究的目的是评价该药的安全性、耐受性和安全性。 三种剂量(200 mg、300 mg、400 mg)的药代动力学 口服伏立康唑与(主动)对照(氟康唑为400 毫克/天)，在血液病/疾病患者中，固体 肿瘤，或接受自体骨髓移植的患者有风险 曲霉病的发展。 这项随机、双盲、积极对照的研究将 在三个或更多的站点，在最多三个连续的阶段。在每个阶段 在这项研究中，将依次招募足够数量的患者 产生12个可评价的案例。这项研究刚刚启动了患者 应计费用。就本议定书而言，可评价的案例将是 定义如下：1)已完成整整14天的患者 治疗期间；或2)因以下原因停止治疗的患者 与治疗相关的不良事件。

The objective of this study is to evaluate the safety, tolerance and pharmacokinetics of three doses (200 mg BID, 300 mg BID, and 400 mg BID) of oral voriconazole, compared to an (active) control (fluconazole at 400 mg/day), in patients with hematologic malignancies/conditions, solid tumors, or patients with autologous bone marrow transplants at risk for development of aspergillosis. This randomized, double-blind, active-controlled study will be conducted in up to three sequential phases, at three or more sites. In each phase of the study, a sufficient number of patients will be recruited in order to produce 12 evaluable cases. This study has just initiated patient accrual. For the purpose of this protocol, an evaluable case will be defined as follows: 1) a patient that has completed the full 14-day treatment period; or 2) a patient that has been discontinued because of a treatment-related adverse event.