NCT01390805

Brief Summary

The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2.4 years

First QC Date

July 7, 2011

Last Update Submit

May 15, 2017

Conditions

Genital Herpes

Outcome Measures

Primary Outcomes (1)

  • The number of adverse events in Japanese subjects with recurrent genital herpes treated with valaciclovir

    1 year

Study Arms (1)

Subjects with recurrent genital herpes

Drug: Valaciclovir Hydrochloride.

Interventions

Valaciclovir Hydrochloride.DRUG
Subjects with recurrent genital herpes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Japanese subjects with recurrent genital herpes

You may qualify if:

  • Subjects who started suppressive therapy for recurrent genital herpes for the first time

You may not qualify if:

  • Subjects with a history of hypersensitivity to the ingredients of VALTREX or aciclovir

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsHerpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 11, 2011

Study Start

November 1, 2006

Primary Completion

April 1, 2009

Study Completion

March 1, 2011

Last Updated

May 16, 2017

Record last verified: 2017-05