A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

September 8, 2017 updated by: GlaxoSmithKline

An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.

Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7580206
        • GSK Investigational Site
  • South Africa
      • Brits, South Africa, 2000
        • GSK Investigational Site
      • George, South Africa, 6529
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • GSK Investigational Site
    • California
      • San Diego, California, United States, 92123
        • GSK Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32209
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40202
        • GSK Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • GSK Investigational Site
    • Texas
      • Galveston, Texas, United States, 77555-0653
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Subjects who have a current herpes virus infection.
  • Have neonatally acquired herpes at risk of potential recurrence.
  • Immunocompromised or cancer patients at risk for development of a herpes virus infection.

Exclusion criteria:

  • Hypersensitivity to antiherpetic medications.
  • Impaired hepatic or renal function.
  • Show presence of other serious or unstable underlying disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Subjects in the age group of 2 to less than 6 years will be included
Drug: Valaciclovir
Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Experimental: Cohort 2
Subjects in the age group of 1 to less than 2 years will be included
Drug: Valaciclovir
Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Experimental: Cohort 3
Subjects in the age group of 6 months to less than 1 year will be included
Drug: Valaciclovir
Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Experimental: Cohort 4
Subjects in the age group of 3 months to less than 6 months will be included
Drug: Valaciclovir
Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.
Experimental: Cohort 5
Subjects in the age group of 1 month to less than 3 months will be included
Drug: Valaciclovir
Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose.
Time Frame: 0.5, 1, 2, 4 and 6 hours
0.5, 1, 2, 4 and 6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.
Time Frame: Up to Day 5
Up to Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2003

Primary Completion (Actual)

February 28, 2007

Study Completion (Actual)

February 28, 2007

Study Registration Dates

First Submitted

February 24, 2006

First Submitted That Met QC Criteria

February 24, 2006

First Posted (Estimate)

February 28, 2006

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS210914

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: HS210914
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: HS210914
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: HS210914
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: HS210914
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: HS210914
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: HS210914
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: HS210914
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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