Last updated: 11/07/2018 10:07:09
Valaciclovir hydrochloride Phase III for Hematopoietic Stem Cell Transplantation patients
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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 hematopoietic stem cell transplantation patients
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with a herpes simplex virus (HSV) infection
Timeframe: From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)
Secondary outcomes:
Number of participants with any adverse event (AE) or any serious adverse event (SAE)
Timeframe: From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)
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
Timeframe: Screening (SCR), Day 14, and Day 35
Mean direct bilirubin, total bilirubin, creatinine, and uric acid values at Screening, Day 14, and Day 35
Timeframe: Screening (SCR), 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
Timeframe: Screening (SCR), Day 14, and Day 35
Mean albumin and total protein values at Screening, Day 14, and Day 35
Timeframe: Screening (SCR), Day 14, and Day 35
Mean basophil, eosinophil, lymphocyte, monocyte, and total neutrophil values at Screening, Day 14, and Day 35
Timeframe: Screening (SCR), Day 14, and Day 35
Mean platelet count and white blood cell (WBC) count at Screening, Day 14, and Day 35
Timeframe: Screening (SCR), Day 14, and Day 35
Mean red blood cell count at Screening, Day 14, and Day 35
Timeframe: Screening (SCR), Day 14, and Day 35
Mean hemoglobin values at Screening, Day 14, and Day 35
Timeframe: Screening (SCR), 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
Timeframe: Screening (SCR), Day 14, and 35
Mean urine specific gravity values at Screening, Day 14, and Day 35
Timeframe: Screening (SCR), Day 14, and Day 35
Change from Baseline in systolic blood pressure and diastolic blood pressure at Days 0, 7, 14, 21, and 35
Timeframe: Baseline; Days 0, 7, 14, 21, and 35
Change from Baseline in heart rate at Days 0, 7, 14, 21, and 35
Timeframe: Baseline; Days 0, 7, 14, 21, and 35
Number of participants with the indicated electrocardiogram (ECG) findings at Screening and Day 35
Timeframe: Screening (SCR) and Day 35
Interventions:
Drug: VACV tablets (Adults or pediatrics) or granules (pediatrics)
Enrollment:
40
Observational study model:
Not applicable
Primary completion date:
2013-24-05
Time perspective:
Not applicable
Clinical publications:
Kazuaki Suyama, Tomomi Yoshida, Akihiro Kobayashi.A clinical study to evaluate preventive efficacy of valaciclovir hydrochloride for herpes simplex virus infection in hematopoietic stem cell transplantation patients.J Clin Therapeut Med.2014;30(7)
Medical condition
Herpes Simplex
Product
valaciclovir
Collaborators
Not applicable
Study date(s)
May 2012 to May 2013
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
1 - 64 years
Accepts healthy volunteers
No
- 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 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.
Inclusion and exclusion 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-24-05
Actual study completion date
2013-24-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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