A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes

Phase 2

Completed

• Conditions: Herpes Genitalis
• Interventions: Drug: ASP2151; Drug: Placebo; Drug: valacyclovir

• Registration Number: NCT00486200
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-12
• Study First Posted: 2007-06-14
• Study Start: 2007-06-21
• Primary Completion: 2008-08-12
• Study Completion: 2008-08-12
• Disposition First Submitted: 2010-01-04
• Disposition First Submitted QC: 2010-01-04
• Disposition First Posted: 2010-01-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 695

Inclusion Criteria

• Subject has a history of genital HSV documented by laboratory testing at screening
• Subject has experienced 4 or more episodes of genital herpes during the past 12 months

Exclusion Criteria

• Subject is immunocompromised

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	ASP2151	Dosing regimen 2
6	ASP2151	Dosing regimen 4
3	ASP2151	Dosing regimen 1
2	Placebo	Oral administration of placebo
5	ASP2151	Dosing regimen 3
1	valacyclovir	Oral administration of active comparator

Primary Outcome Measures

Name	Time	Method
To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection	17 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics in study patients	4 days