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

Astellas

Status and phase: Completed; Phase 2

Conditions: Herpes Genitalis

Treatments: Drug: ASP2151; Drug: valacyclovir; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486200

15L-CL-101

Details and patient eligibility

About

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

Enrollment: 695 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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695 participants in 6 patient groups, including a placebo group

1

Active Comparator group

Description:

Oral administration of active comparator

Treatment:

Drug: valacyclovir

2

Placebo Comparator group

Description:

Oral administration of placebo

Treatment:

Drug: Placebo

3

Experimental group

Description:

Dosing regimen 1

Treatment:

Drug: ASP2151

4

Experimental group

Description:

Dosing regimen 2

Treatment:

Drug: ASP2151

5

Experimental group

Description:

Dosing regimen 3

Treatment:

Drug: ASP2151

6

Experimental group

Description:

Dosing regimen 4

Treatment:

Drug: ASP2151