PER-061-08已完成未知
Open Label Study of Isavuconazole in the Treatment of Patients with Aspergillosis and Renal Impairment or of Patients with Invasive Fungal Disease Caused by Rare Molds, Yeasts or Dimorphic Fungi.
BASILEA PHARMACEUTICA INTERNATIONAL LTD.,0 个研究点目标入组 0 人开始时间: 2008年11月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65（—）
入选标准
- •Patients who have been fully informed and have voluntarily given written informed consent or whose legally authorized representative (s) have been fully informed and have voluntarily given written informed consent. , in his case or patients unable to write and / or read but who fully understand the information verbally provided by the researcher (or his designated representative) who have verbally granted their informed consent, which has been witnessed in writing by an Independent person.
- •Ability and willingness to comply with the protocol
- •Male and female patients> 18 years of age
- •Female patients should not be breastfeeding or at risk of becoming pregnant due to any of the following reasons: - they have been postmenopausal for at least 1 year - they have undergone a hysterectomy and / or bilateral ovariectomy - if they are potentially fertile , who obtained a negative result in the pregnancy test of human chorionic gonadotropin (hcg) in urine or serum in the selection and who are using a highly effective method of birth control throughout the study. Responsible sexual abstinence throughout the study is as acceptable as a highly effective method of birth control for the purposes of this study.
- •Patients included in one of the following 2 subgroups: Patients with proven or probable invasive aspergillosis and patients with proven IFD caused by uncommon molds, yeasts or dimorphic fungi
排除标准
- •Pregnant or lactating women.
- •Known history of allergy, hypersensitivity or any serious reaction to azole antifungals or to any component of the study medication.
- •Patients with a high risk of prolongation of the QT / QTc interval, for example with a family history of prolonged QT syndrome or another form of known pro-arrhythmia.
- •Evidence of severe hepatic dysfunction with any of the following abnormal laboratory parameters at the screening visit: - Total bilirubin x 3 times the upper limit of normal (ULN) - Alanine transaminase (ALT) or aspartate transaminase (ASI) x 5 times the ULN
- •Concomitant use of astemizole, cisapride, rifampicin, rifabutin, ergot alkaloids. long-acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine or terfenadine, in the 5 days prior to the first administration of the study medication.
- •Patients-with-aspergillosiscronicaraspergiloma-o-ABRA
- •Microbiological findings (eg, virological) or other potentially temporally related conditions that suggest an alternative etiology of clinical features
- •Advanced infection by human immunodeficiency virus with a CD4 count <200 or condition defined as acquired immunodeficiency syndrome.
- •Any known or suspected patient condition that may jeopardize adherence to protocol requirements or Prevent accurate measurement of efficacy (eg, neutropenia, when not expected to resolve, patients with endocarditis, osteomyelitis, meningitis) , uncontrolled malignant disease (palliative therapy, refractory to treatment only), with life expectancy of less than 30 days.
- •Patients with a concomitant medical condition that, in the opinion of the investigator, may constitute an unacceptable additional risk to the patient´s health if they participate in the study.
- •Patients previously enrolled in a phase III study with isavuconazole. (NB patients may be transferred from study WSA-CS-004 if mycology identifies zygomycetes, which is not expected to be susceptible to voriconazole).
- •Treatment with any investigational drug in any clinical trial within the
- •30 days prior to the first administration of the medication under study, except for non-blind studies in phase III.
- •Patients who are not likely to survive more than 5 days.
研究者
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