Herpes simplex virus (HSV) infection before and after hematopoietic stem cell transplantation.
Conditions
Interventions
Trade Name: Valtrex
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VALACICLOVIR HYDROCHLORIDE
Other descriptive name: VALACICLOVIR HYDROCHLORIDE
Concentration unit: mg milligram(s)
Conce
Sponsors
GlaxoSmithKline K.K. (GSK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 1.5xULN was acceptable if direct bilirubin was =65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety • Adverse events • Laboratory results (hematology, clinical chemistry, urinalysis) • Vital signs (body temperature, blood pressure, pulse rate) • 12-lead ECG ;Timepoint(s) of evaluation of this end point: Day 0 (hematopoietic stem cell transplantation) to Day 35. | — |
Countries
Japan
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed