Phase 3
N=40
Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients
Herpes Simplex
Bottom Line
View on ClinicalTrials.gov: NCT01602562 ↗Enrolled (actual)
40
Serious AEs
7.5%
Results posted
Feb 2014
Primary outcome: Primary: Number of Participants With a Herpes Simplex Virus (HSV) Infection — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- VACV tablets (Adults or pediatrics) or granules (pediatrics) (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Herpes Simplex Virus (HSV) Infection |
0; 0 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) |
13; 11; 2; 1 | — |
| SECONDARY 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 |
247.1; 598.8; 358.7; 456.7; 314.9; 519.9 | — |
| SECONDARY Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35 |
2.931; 2.970; 7.410; 3.923; 2.351; 2.565 | — |
| SECONDARY Mean Cholesterol, Chloride, Glucose, Potassium, Sodium, Triglyceride, and Urea/Blood Urea Nitrogen (BUN) Values at Screening, Day 14, and Day 35 |
4.8149; 4.1703; 4.0255; 3.5504; 5.5324; 4.1279 | — |
| SECONDARY Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35 |
41.0; 41.5; 34.6; 39.1; 40.8; 40.9 | — |
| SECONDARY Mean Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Screening, Day 14, and Day 35 |
1.05; 0.49; 0.69; 0.14; 1.09; 0.59 | — |
| SECONDARY Mean Platelet Count and White Blood Cell (WBC) Count at Screening, Day 14, and Day 35 |
190.2; 167.7; 40.3; 58.2; 139.4; 119.0 | — |
| SECONDARY Mean Red Blood Cell Count at Screening, Day 14, and Day 35 |
3.165; 3.293; 2.932; 2.908; 3.297; 3.073 | — |
| SECONDARY Mean Hemoglobin Values at Screening, Day 14, and Day 35 |
101.6; 99.3; 91.6; 85.1; 106.5; 94.4 | — |
| SECONDARY Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Screening, Day 14, and Day 35 |
21; 19; 18; 17; 16; 16 | — |
| SECONDARY Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35 |
1.0146; 1.0188; 1.0158; 1.0155; 1.0137; 1.0153 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Days 0, 7, 14, 21, and 35 |
-1.8; -4.7; 0.9; -6.1; 4.3; -7.6 | — |
| SECONDARY Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35 |
1.1; -1.0; 13.3; 3.8; 12.5; 3.6 | — |
| SECONDARY Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35 |
16; 19; 5; 0; 0; 0 | — |
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 1.5xULN is acceptable if direct bilirubin =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.
Data sourced from ClinicalTrials.gov (NCT01602562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.