EUCTR2005-002800-40-GR进行中（未招募）不适用
Prospective, Open-label, Comparative, Multicenter Study of Voriconazole Compared to Itraconazole for the Primary Prophylaxis of Invasive Fungal Infections (IFI) in Subjects with Allogeneic Hematopoietic Stem Cell Transplants (HSCT) - N/A
未提供0 个研究点目标入组 500 人开始时间: 2006年12月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •·Males or females = 12 years of age.
- •·Subjects who will be receiving allogeneic HSCT for acute leukemia (AML, ALL or myelodysplastic syndrome) failure of therapy for lymphoma or transformation of chronic myeloid leukemia
- •·Signed and dated informed consent will be obtained from each subject in accordance with the local regulatory and legal requirements
- •·Females of childbearing potential must have a negative serum b-HCG pregnancy test and use an approved method of contraception throughout the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following must not be included in the trial:
- •·Probable or proven IFI at study entry or at any time in 6 months prior to study entry, defined according to the consensus criteria” (Ascioglu et al 2002 ).
- •·Any previous history of zygomycosis (e.g. Mucor, Absidia, Rhizopus).
- •·Use of any systemically active antifungal agent within the 7 days prior to study entry.
- •·Allergy to study drugs or any excipients.
- •·Abnormal laboratory test results, defined as impaired hepatic function, as shown by transaminases or alkaline phosphatase, > 5 x Upper Limit of Normal [ULN], bilirubin >2.5mg/dL.
- •·Severe disease other than underlying condition, likely to jeopardize the planned termination of the study (e.g. acute myocardial infarction, unstable angina pectoris, potentially pro-arrhythmic conditions such as cardiac impairment due to previous cardiotoxic chemotherapy, previous torsade de pointes, prolongation of the QT interval > 450 msec for men or > 470 msec for women).
- •·Concomitant use of sirolimus, ergot alkaloids, terfenadine, astemizole, cisapride, pimozide, quinidine, carbamazepine, rifampicin, phenobarbital, ritonavir or efavirenz which might interfere with the evaluation of study drugs during the study.
- •·Alcohol and/or any other drug abuse.
- •·Previous participation in this trial.
- •·Unable and/or unlikely to comprehend and/or follow the protocol.
- •·Participation in any other studies involving investigational products, concomitantly or within 30 days prior to entry in the study.
- •·Anticipated survival less than one month.
研究者
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已完成
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