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

A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00486200

Enrollment

695

Registered

2007-06-14

Start date

2007-06-21

Completion date

2008-08-12

Last updated

2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Genitalis

Keywords

ASP2151, Herpes Genitalis, Sexually Transmitted Disease, Herpes Simplex Virus Genital Infection, Treatment Outcome, Genital Herpes

Brief summary

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

Interventions

DRUGASP2151

Oral administration.

DRUGvalacyclovir

Oral administration of active comparator.

DRUGPlacebo

Oral administration of placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Pharmacokinetics in study patients	4 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026