EUCTR2004-003657-99-GB进行中（未招募）1 期
A double-blind, randomised, placebo controlled study to evaluate the safety and efficacy of A-60444 in adults with RSV infection following stem cell transplantation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
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
- •1. Patients diagnosed with RSV infection who have had a stem cell transplant.
- •2. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation or who have been post-menopausal for at least two years, or are considered to be sterile due to recent chemotherapy.
- •3. Aged between 18 and 65 years.
- •4. Patients who have given their written informed consent to participate in the study.
- •5. Patients who are willing and able to comply with the protocol and study procedures.
- •Are the trial subjects under 18? no
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who have received an investigational drug within one month preceding the start of dosing.
- •2. Patients who have a documented history of allergy to benzodiazepines.
- •3. Patients with significant hepatic impairment (alanine transaminase (ALT) > 5 x upper level of normal (ULN), total bilirubin > 3 x ULN). Biochemistry data collected less than or equal to four weeks prior to screening is acceptable.
- •4. Patients, who in the opinion of their general practitioner or the Investigator, should not participate in the study.
研究者
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