Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients
NCT ID: NCT01602562
Last Updated: 2018-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2012-05-07
2013-05-24
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
VACV tablets (Adults or pediatrics) or granules (pediatrics)
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.
Interventions
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VACV tablets (Adults or pediatrics) or granules (pediatrics)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
1 Year
64 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Aichi, , Japan
GSK Investigational Site
Aichi, , Japan
GSK Investigational Site
Aichi, , Japan
GSK Investigational Site
Hiroshima, , Japan
GSK Investigational Site
Hyōgo, , Japan
GSK Investigational Site
Hyōgo, , Japan
GSK Investigational Site
Kagoshima, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Tokyo, , Japan
Countries
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Study Documents
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Document Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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116100
Identifier Type: -
Identifier Source: org_study_id
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