Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients

NCT01602562 | Completed Phase 3 Results

• 1 other identifier: 116100
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 11

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.

Conditions

Herpes Simplex

Keywords

Herpes simplex infection; valaciclovir; herpes simplex virus; hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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

  Screening (SCR), Day 14, and Day 35

• Mean Direct Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Screening, Day 14, and Day 35

  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

  Screening (SCR), Day 14, and Day 35

• Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35

  Screening (SCR), Day 14, and Day 35

Study Arms (1)

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.

Drug: VACV tablets (Adults or pediatrics) or granules (pediatrics)

Interventions

VACV tablets (Adults or pediatrics) or granules (pediatrics) DRUG

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.

Also known as: 256U87 tablet or granule

VACV (256U87; valaciclovir hydrochloride)

Eligibility Criteria

• Age: 1 Year - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Aichi, 446-8602, Japan

Location

GSK Investigational Site

Aichi, 453-8511, Japan

Location

GSK Investigational Site

Aichi, 466-8560, Japan

Location

GSK Investigational Site

Hiroshima, 734-8551, Japan

Location

GSK Investigational Site

Hyōgo, 650-0047, Japan

Location

GSK Investigational Site

Hyōgo, 654-0081, Japan

Location

GSK Investigational Site

Kagoshima, 890-8520, Japan

Location

GSK Investigational Site

Kanagawa, 259-1143, Japan

Location

GSK Investigational Site

Osaka, 594-1101, Japan

Location

GSK Investigational Site

Saitama, 339-8551, Japan

Location

GSK Investigational Site

Tokyo, 162-8655, Japan

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 21, 2012
• Study Start: May 7, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 24, 2013
• Last Updated: August 17, 2018
• Results First Posted: February 24, 2014

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

JP (11)