Evaluation of preventive efficacy of valaciclovir hydrochloride in herpes simplex virus infection for hematopoietic stem cell transplantation patients.
- Conditions
- Herpes simplex virus (HSV) infection before and after hematopoietic stem cell transplantation.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-004869-88-Outside-EU/EEA
- Lead Sponsor
- GlaxoSmithKline K.K. (GSK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the preventive efficacy of valaciclovir hydrochloride (VACV) for herpes simplex virus (HSV) infection before and after hematopoietic stem cell transplantation (HSCT) in the adult and pediatric HSCT patients.;Secondary Objective: To evaluate the safety of VACV in the case of its administration to the adult and pediatric HSCT patients.;Timepoint(s) of evaluation of this end point: Day 0 (hematopoietic stem cell transplantation) to Day 35.;Primary end point(s): Incidence of HSV infection (primary endpoint) - definition of HSV infection: If an investigator (or a treating physician) suspects HSV infection according to the clinical symptoms, he/she attempts to isolate/identify the virus. If a positive result is obtained in the viral isolation/identification, the patient is defined as a case of HSV infection. For reference, PCR-based viral DNA identification is simultaneously conducted.<br><br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Safety<br>•Adverse events<br>•Laboratory results (hematology, clinical chemistry, urinalysis)<br>•Vital signs (body temperature, blood pressure, pulse rate)<br>•12-lead ECG<br>;Timepoint(s) of evaluation of this end point: Day 0 (hematopoietic stem cell transplantation) to Day 35.