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Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients

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ClinicalTrials.gov Identifier: NCT01602562
Recruitment Status : Completed
First Posted : May 21, 2012
Results First Posted : February 24, 2014
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Herpes Simplex
Intervention: Drug: VACV tablets (Adults or pediatrics) or granules (pediatrics)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Adult Participants: VACV 500 mg Tablet Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
Pediatric Participants: VACV 500 mg Granules/Tablets Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).

Participant Flow:   Overall Study
    Adult Participants: VACV 500 mg Tablet   Pediatric Participants: VACV 500 mg Granules/Tablets
STARTED   21   19 
COMPLETED   16   16 
NOT COMPLETED   5   3 
Adverse Event                3                1 
Physician Decision                1                1 
Withdrawal by Subject                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Adult Participants: VACV 500 mg Tablet Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
Pediatric Participants: VACV 500 mg Granules/Tablets Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
Total Total of all reporting groups

Baseline Measures
   Adult Participants: VACV 500 mg Tablet   Pediatric Participants: VACV 500 mg Granules/Tablets   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   19   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.6  (14.32)   7.5  (4.69)   29.1  (23.40) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  42.9%      7  36.8%      16  40.0% 
Male      12  57.1%      12  63.2%      24  60.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian - Japanese Heritage   21   19   40 


  Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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) ]

3.  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   [ Time Frame: Screening (SCR), Day 14, and Day 35 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   Mean Albumin and Total Protein Values at Screening, Day 14, and Day 35   [ Time Frame: Screening (SCR), Day 14, and Day 35 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   Mean Red Blood Cell Count at Screening, Day 14, and Day 35   [ Time Frame: Screening (SCR), Day 14, and Day 35 ]

10.  Secondary:   Mean Hemoglobin Values at Screening, Day 14, and Day 35   [ Time Frame: Screening (SCR), Day 14, and Day 35 ]

11.  Secondary:   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 ]

12.  Secondary:   Mean Urine Specific Gravity Values at Screening, Day 14, and Day 35   [ Time Frame: Screening (SCR), Day 14, and Day 35 ]

13.  Secondary:   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 ]

14.  Secondary:   Change From Baseline in Heart Rate at Days 0, 7, 14, 21, and 35   [ Time Frame: Baseline; Days 0, 7, 14, 21, and 35 ]

15.  Secondary:   Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Screening and Day 35   [ Time Frame: Screening (SCR) and Day 35 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01602562     History of Changes
Other Study ID Numbers: 116100
First Submitted: May 17, 2012
First Posted: May 21, 2012
Results First Submitted: January 9, 2014
Results First Posted: February 24, 2014
Last Update Posted: August 17, 2018