Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)

Completed

• Conditions: Genital Herpes
• Interventions: Drug: Valaciclovir Hydrochloride.

• Registration Number: NCT01390805
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2009-04
• Study Completion: 2011-03
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-11
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with recurrent genital herpes	Valaciclovir Hydrochloride.	-

Primary Outcome Measures

Name	Time	Method
The number of adverse events in Japanese subjects with recurrent genital herpes treated with valaciclovir	1 year