CClinicalTrials.gg
CompletedNCT00486200Updated Dec 7, 2017

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

A Phase 2 interventional study of ASP2151 and valacyclovir in Herpes Genitalis, sponsored by Astellas Pharma Inc. Completed at 25 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
695
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Herpes Genitalis

Keywords

  • ASP2151
  • Herpes Genitalis
  • Sexually Transmitted Disease
  • Herpes Simplex Virus Genital Infection
  • Treatment Outcome
  • Genital Herpes
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 695 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subject is immunocompromised
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
695 participants (actual)

Study arms

  • Active comparator
    1

    Oral administration of active comparator

    Drug: valacyclovir

  • Placebo comparator
    2

    Oral administration of placebo

    Drug: Placebo

  • Experimental
    3

    Dosing regimen 1

    Drug: ASP2151

  • Experimental
    4

    Dosing regimen 2

    Drug: ASP2151

  • Experimental
    5

    Dosing regimen 3

    Drug: ASP2151

  • Experimental
    6

    Dosing regimen 4

    Drug: ASP2151

Interventions

  • DrugASP2151

    Oral administration.

  • Drugvalacyclovir

    Oral administration of active comparator.

  • DrugPlacebo

    Oral administration of placebo.

06

What researchers measure

Primary outcomes

  1. To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection

    Time frame: 17 days

Secondary outcomes

  1. Pharmacokinetics in study patients

    Time frame: 4 days

07

Study locations

25 sites
  • Birmingham, Alabama 35294, United States
  • Phoenix, Arizona 85015, United States
  • Tucson, Arizona 85712, United States
  • Los Angeles, California 90017, United States
  • Sacramento, California 95821, United States
  • San Diego, California 92108, United States
  • Westlake Village, California 91361, United States
  • Denver, Colorado 80262, United States
  • Boynton Beach, Florida 33472, United States
  • Miami, Florida 33156, United States
  • Atlanta, Georgia 30328, United States
  • Indianapolis, Indiana 46202, United States
  • Madisonville, Kentucky 42431, United States
  • Baltimore, Maryland 21201, United States
  • Billings, Montana 59101, United States
  • Omaha, Nebraska 68134, United States
  • Albuquerque, New Mexico 87131, United States
  • Portland, Oregon 97210, United States
  • Philadelphia, Pennsylvania 19103, United States
  • Arlington, Texas 76011, United States
  • Houston, Texas 77030, United States
  • Houston, Texas 77058, United States
  • Salt Lake City, Utah 84132, United States
  • Annandale, Virginia 22003, United States
  • Seattle, Washington 98122, United States
08

References and documents

Publications

  • Tyring S, Wald A, Zadeikis N, Dhadda S, Takenouchi K, Rorig R. ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study. J Infect Dis. 2012 Apr 1;205(7):1100-10. doi: 10.1093/infdis/jis019. Epub 2012 Feb 20. PubMed 22351940 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00486200
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Jun 14, 2007
Start date
Jun 21, 2007
Primary completion
Aug 12, 2008
Completion
Aug 12, 2008
Last update
Dec 7, 2017

Study contacts

Use Central Contact
study director · Astellas Pharma US, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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