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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With a Herpes Simplex Virus (HSV) Infection
研究概览
简要总结
The purpose of this study is to evaluate the preventive efficacy for HSV infection and safety of valaciclovir (VACV) in the adult and pediatric HSCT patients.
详细描述
This clinical study is a multicenter open-label study on the adult and pediatric hematopoietic stem cell transplantation (HSCT) patients. The primary objective is to confirm the preventive efficacy for herpes simplex virus (HSV) infection of 256U87 (VACV: valaciclovir) due to the treatment before or immediately after hematopoietic stem cell transplantation. The secondary objective is to confirm the safety of VACV in the case of its use for such a purpose.
This clinical study consists of the following two periods: the screening period lasting 7 days at the longest and the administration period from 7 days before HSCT to 35 days after HSCT (43 days in total). During the administration period, adult patients are orally given a VACV tablet twice daily, while pediatric patients are orally given VACV granules twice daily at a dose of 25 mg/kg b.w. (maximum dose per treatment: 500 mg). Pediatric patients weighing 40 kg or over may be orally given a VACV tablet twice daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are planning to undergo hematopoietic stem cell transplantation, except cord blood transplantation.
- •Patients aged from 1 and above to under 65 at the time of informed consent.
- •Patients who can submit their voluntary written informed consent if they are 12 years old and over.
- •Patient is male or female. Male patients must be willing to use adequate contraception during the study. Female patients of childbearing potential must agree to consistently perform any of the contraceptive methods.
- •QTc <450 msec, or QTc <480 msec in patients with bundle branch block. (values based on either single ECG values or triplicate ECG averaged QTc values)
- •Liver test (aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase (Al-P)and total bilirubin <=1.5xULN (total bilirubin >1.5xULN is acceptable if direct bilirubin <35%).
排除标准
- •Patients with a history of HSCT.
- •Patients who are judged to be in the following condition by the investigator (or subinvestigator): the clinical severity of malabsorption syndrome, vomiting, mucositis or other gastrointestinal dysfunction is so serious that orally administered VACV can not be absorbed.
- •Patients who have known nucleoside analogs hypersensitivity.
- •Patients who have a concurrent or past history of renal function disorder (serum creatinine >=1.5x ULN).
- •Patients who have serious complication (eg, other malignant tumours, cardiac disorder, juvenile diabetes).
- •Patients who are currently treated with the prohibited concomitant drugs.
- •Patients with evidence of chronic hepatitis B or C.
- •Patients with AIDS or patients infected with HIV.
- •Patients who were given other trial products within 30 days before initiation of administration of this trial product or those who intend to participate in other clinical trials.
- •Patients who are pregnant or probably pregnant.
- •Patients who can not follow the protocol because of psychological, family, social or geological reasons.
- •Patients are not allowed to participate in this clinical trial if the investigator (or subinvestigator) judges that their participation is inappropriate.
研究组 & 干预措施
VACV (256U87; valaciclovir hydrochloride)
Adult patients (16-65 years): A VACV tablet (containing 500mg of valaciclovir) is orally given twice daily. Pediatric patients (1-16 years): VACV granules are orally given at a dose of 25 mg/kg b.w. twice daily. The maximum dose per treatment is limited to 500 mg. Pediatric patients weighing 40 kg or over may be orally given a VACV tablet (containing 500 mg of valaciclovir) twice daily.
干预措施: VACV tablets (Adults or pediatrics) or granules (pediatrics) (Drug)
结局指标
主要结局
Number of Participants With a Herpes Simplex Virus (HSV) Infection
时间窗: From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)
Viral isolation/identification was conducted if the investigator (or subinvestigator) suspected HSV infection according to the relevant clinical symptoms (oral mucositis, skin infection, genital herpes, and pneumonia). If the result of viral isolation/identification was positive, the participant concerned was defined as a case of HSV infection. For reference, a virus deoxyribonucleic acid (DNA) identification (PCR) was simultaneously performed.
次要结局
- Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and 35)
- Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and Day 35)
- Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35(Baseline; Days 0, 7, 14, 21, and 35)
- Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35(Baseline; Days 0, 7, 14, 21, and 35)
- Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)(From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT))
- Mean Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), Gamma Glutamyl Transferase (GGT), and Lactate Dehydrogenase (LD) Values at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and Day 35)
- Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and Day 35)
- Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and Day 35)
- Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and Day 35)
- Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and Day 35)
- Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and Day 35)
- Mean Red Blood Cell Count at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and Day 35)
- Mean Hemoglobin Values at Screening, Day 14, and Day 35(Screening (SCR), Day 14, and Day 35)
- Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35(Screening (SCR) and Day 35)