Clinical Trial: Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open-label Study to Evaluate Preventive Efficacy for Herpes Simplex Virus Infection and Safety of 256U87 (Valaciclovir Hydrochloride) in Adult and Pediatric

Brief 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.

Detailed Summary:

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.


Sponsor: GlaxoSmithKline

Current Primary Outcome: Number of Participants With a Herpes Simplex Virus (HSV) Infection [ Time Frame: 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.


Original Primary Outcome: Incidence of HSV infection [ Time Frame: administration period of 43 days (plus 7 days) ]

Current Secondary Outcome:

  • Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) [ Time Frame: From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT) ]
    An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.
  • 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 [ Time Frame: Screening (SCR), Day 14, and Day 35 ]
    Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35.
  • Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 [ Time Frame: Screening (SCR), Day 14, and Day 35 ]
    Blood samples were collected for the measurement of direct bilirubin, total bilirubin, creatinine, and uric acid at Screening, 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 [ Time Frame: Screening (SCR), Day 14, and Day 35 ]
    Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35.
  • Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 [ Time Frame: Screening (SCR), Day 14, and Day 35 ]
    Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.
  • Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 [ Time Frame: Screening (SCR), Day 14, and Day 35 ]
    Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at Screening, Day 14, and Day 35.
  • Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 [ Time Frame: Screening (SCR), Day 14, and Day 35 ]
    Blood samples were collected for the measurement of platelet count and WBC count at Screening, Day 14, and Day 35.
  • Mean Red Blood Cell Count at Screening, Day 14, and Day 35 [ Time Frame: Screening (SCR), Day 14, and Day 35 ]
    Blood samples were collected for the measurement of the red blood cell count at Screening, Day 14, and Day 35.
  • Mean Hemoglobin Values at Screening, Day 14, and Day 35 [ Time Frame: Screening (SCR), Day 14, and Day 35 ]
    Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.
  • Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 [ Time Frame: Screening (SCR), Day 14, and 35 ]
    Urinalysis parameters included: urine bilirubin (UB), urine occult blood (UOB), urine glucose (UG), urine ketones (UK), urine protein (UP), and urine urobilinogen (UUG). The dipstick is a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameters can be read as negative (Neg), Trace, 1+, 2+, and 3+ (in order of increasing levels). Data are reported as the number of participants who had Neg, Trace, 1+, 2+, and 3+ levels at Screening, Day 14, and Day 35. If a category has not been reported for a specific parameter, then no participants were measured in that category.
  • Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 [ Time Frame: Screening (SCR), Day 14, and Day 35 ]
    Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the Safety Population.
  • Change From Baseline in Systolic Blood Pressure and Diastolic Blood

    Original Secondary Outcome:

    • Adverse events [ Time Frame: from at screening to 35 days after HSCT ]
    • Laboratory results (hematology, clinical chemistry, urinalysis) [ Time Frame: at screening, Day 14, 35 ]
    • Vital signs (body temperature, blood pressure, pulse rate) [ Time Frame: at screening, Day -7, 0, 7, 14, 21, 35 ]
    • 12-lead ECG [ Time Frame: at screening, Day 35 ]


    Information By: GlaxoSmithKline

    Dates:
    Date Received: May 17, 2012
    Date Started: May 2012
    Date Completion:
    Last Updated: November 18, 2016
    Last Verified: November 2016