Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients
Condition: Herpes Simplex
MeSH terms: Herpes Simplex
Intervention: VACV tablets (Adults or pediatrics) or granules (pediatrics)
Intervention description: A white to slightly yellowish white film coated tablet contains 556 mg of valaciclovir hydrochloride (500 mg of valaciclovir)). VACV granules have no or slightly specific odor.
Intervention MeSH terms: Valacyclovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 1 Year
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Herpes simplex infection; valaciclovir; herpes simplex virus; hematopoietic stem cell transplantation

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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%).

        Exclusion Criteria:

          -  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.