EUCTR2015-004869-88-Outside-EU/EEA进行中（未招募）1 期
A multicenter, open-label study to evaluate preventive efficacy for herpes simplex virus infection and safety of 256U87 (valaciclovir hydrochloride) in adult and pediatric hematopoietic stem cell transplantation patients.
GlaxoSmithKline K.K. (GSK)0 个研究点目标入组 40 人开始时间: 2016年12月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •A patient was considered eligible for inclusion in the study only if all of the following criteria applied:
- •1. Patients who were planning to undergo HSCT, except cord blood transplantation.
- •2. Patients aged =1 to < 65 years at the time of informed consent.
- •3. Patients who were able to submit their voluntary written informed consent if they were =12 years old.
- •Patients’ guardians (parents etc.) were also required to submit the written informed consent if the patients were minors. Patients’ guardians (parents etc.) were required to submit the written informed consent if the patients were <12 years old.
- •4. Male or female patients. For male patients, only those who could practice contraception during the study period were eligible. Female patients of childbearing potential could be enrolled only if they had a negative pregnancy test at the start of screening period. Female patients of childbearing potential had to agree to consistently perform any of the contraceptive methods shown below*.
- •*: Sexual abstinence, oral-contraceptive pill, intrauterine contraceptive device,
- •contraceptive surgery of male partner, double barrier method: condom and an occlusive cap.
- •5. Patients with QTc <450 msec, or for patients with bundle branch block QTc <480 msec (based on a QTc value of single ECG or an average value of triplicate ECGs).
- •6. Patients with AST (GOT) and ALT (GPT) <2x upper limit of normal (ULN) and alkaline phosphatase and total bilirubin =1.5xULN (Total bilirubin >1.5xULN was acceptable if direct bilirubin was <35%).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 19
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •A patient was not eligible for inclusion in this study if any of the following criteria applied:
- •1. Patients with a history of HSCT.
- •2. Patients with malabsorption syndrome, vomiting, mucositis or other gastrointestinal dysfunction which were judged by the investigator (or subinvestigator) to be clinically severe enough to interfere with absorption of orally administered VACV.
- •3. Patients with known nucleoside analogue hypersensitivity.
- •4. Patients with a current or past history of renal dysfunction (serum creatinine =1.5x ULN).
- •5. Patients with a serious concurrent disease (eg, other malignant tumour, cardiac disorder, juvenile diabetes).
- •6. Patients using prohibited concomitant drugs.
- •7. Patients with evidence of chronic hepatitis B or C.
- •8. Patients with AIDS or those infected with HIV.
- •9. Patients who had received other investigational product within 30 days before initiation of administration of VACV or those who intended to participate in other clinical trial.
- •10. Patients who were pregnant or possibly pregnant.
- •11. Patients who could not follow the protocol because of psychological, family, social or geological reasons.
- •12. Patients who were
研究者
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