Herpes SimplexPhase 3NCT01602562
Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients
A Phase 3 study testing VACV tablets (Adults or pediatrics) or granules (pediatrics) in people with Herpes Simplex, run by GlaxoSmithKline at 11 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 64 years
- Conditions the study is for
- Herpes Simplex
- What is being tested?
- VACV tablets (Adults or pediatrics) or granules (pediatrics)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 11 sitesJapan
- Study dates
- 7 May 2012to 24 May 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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%).
Who cannot join
- 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.
Show all 12Show fewer
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
GSK Investigational Site
Aichi, 446-8602
GSK Investigational Site
Aichi, 453-8511
GSK Investigational Site
Aichi, 466-8560
GSK Investigational Site
Hiroshima, 734-8551
GSK Investigational Site
Hyōgo, 650-0047
GSK Investigational Site
Hyōgo, 654-0081
GSK Investigational Site
Kagoshima, 890-8520
GSK Investigational Site
Kanagawa, 259-1143
GSK Investigational Site
Osaka, 594-1101
GSK Investigational Site
Saitama, 339-8551
GSK Investigational Site
Tokyo, 162-8655
About this study
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
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.
Read the detailed description
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.
- Conditions
- Herpes Simplex
- Being tested
- VACV tablets (Adults or pediatrics) or granules (pediatrics)
- Keywords
- Herpes simplex infection, valaciclovir, herpes simplex virus, hematopoietic stem cell transplantation
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VACV tablets (Adults or pediatrics) or granules (pediatrics)Drug
Also called 256U87 tablet or granule
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.
| Study group | Role | What they receive |
|---|---|---|
| VACV (256U87; valaciclovir hydrochloride) | Experimental | 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. Receives: Drug: VACV tablets (Adults or pediatrics) or granules (pediatrics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Herpes Simplex Virus (HSV) Infection
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.
Measured: From Day -7 (7 days before HSCT) to Day 35 (35 days after HSCT)
Secondary outcomes (14)
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
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.
Measured: 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
Blood samples were collected for the measurement of ALP, ALT, AST, CPK, GGT, and LD at Screening, Day 14, and Day 35.
Measured: Screening (SCR), Day 14, and Day 35
Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, 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.
Measured: 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
Blood samples were collected for the measurement of cholesterol, chloride, glucose, potassium, sodium, triglycerides, and urea/BUN at Screening, Day 14, and Day 35.
Measured: Screening (SCR), Day 14, and Day 35
Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of albumin and total protein at Screening, Day 14, and Day 35.
Measured: Screening (SCR), Day 14, and Day 35
Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, 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.
Measured: Screening (SCR), Day 14, and Day 35
Mean Platelet Count and White Blood Cell (WBC) Count at Screening, 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.
Measured: Screening (SCR), Day 14, and Day 35
Mean Red Blood Cell Count at Screening, 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.
Measured: Screening (SCR), Day 14, and Day 35
Mean Hemoglobin Values at Screening, Day 14, and Day 35
Blood samples were collected for the measurement of hemoglobin at Screening, Day 14, and Day 35.
Measured: 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
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.
Measured: Screening (SCR), Day 14, and 35
Mean Urine Specific Gravity Values at Screening, 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.
Measured: 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
Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Days 0, 7, 14, 21, and 35
Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35
Heart rate is defined as the number of heartbeats per unit of time. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline; Days 0, 7, 14, 21, and 35
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35
The number of participants with normal, abnormal - clinically significant (CS), and abnormal - not clinically significant (NCS) ECG findings, as well as the number of participants with no results (NR), at Screening and Day 35 are presented. Findings were determined to be normal, abnormal CS, and NCS by the investigator.
Measured: Screening (SCR) and Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study start7 May 2012
- Primary completion1 May 2013
- Study completion24 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Herpes SimplexStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602562
- Sponsor's protocol ID
- 116100
- Status last verified
- Jun 2018
- First submitted
- 17 May 2012
- Last updated
- 17 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01602562
- Acronym / sponsor ID
- 116100
- Conditions
- Herpes Simplex
- Keywords
- Herpes simplex infection, valaciclovir, herpes simplex virus, hematopoietic stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 7 May 2012
- Primary completion
- 1 May 2013 (actual)
- Study completion
- 24 May 2013 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Posted 24 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VACV (256U87; valaciclovir hydrochloride) | Experimental | Drug: VACV tablets (Adults or pediatrics) or granules (pediatrics)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. |
Who may qualify
- Ages
- 1 year to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VACV tablets (Adults or pediatrics) or granules (pediatrics)Also: 256U87 tablet or granuleA 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. | Drug | VACV (256U87; valaciclovir hydrochloride) |
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.
14 secondary outcomes
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)
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
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
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
Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35
Time frame: Screening (SCR), 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
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
Mean Red Blood Cell Count at Screening, Day 14, and Day 35
Time frame: Screening (SCR), Day 14, and Day 35
Mean Hemoglobin Values at Screening, Day 14, and Day 35
Time frame: 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
Time frame: Screening (SCR), Day 14, and 35
Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35
Time frame: 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
Time frame: Baseline; Days 0, 7, 14, 21, and 35
Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35
Time frame: Baseline; Days 0, 7, 14, 21, and 35
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35
Time frame: Screening (SCR) and Day 35
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VACV tablets (Adults or pediatrics) or granules (pediatrics) in people with Herpes Simplex, run by GlaxoSmithKline at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.