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

December 1, 2017 updated by: Astellas Pharma Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

695

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Oral administration of active comparator
Drug: valacyclovir
Oral administration of active comparator.
Placebo Comparator: 2
Oral administration of placebo
Drug: Placebo
Oral administration of placebo.
Experimental: 3
Dosing regimen 1
Drug: ASP2151
Oral administration.
Experimental: 4
Dosing regimen 2
Drug: ASP2151
Oral administration.
Experimental: 5
Dosing regimen 3
Drug: ASP2151
Oral administration.
Experimental: 6
Dosing regimen 4
Drug: ASP2151
Oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 17 days
17 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics in study patients
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2007

Primary Completion (Actual)

August 12, 2008

Study Completion (Actual)

August 12, 2008

Study Registration Dates

First Submitted

June 12, 2007

First Submitted That Met QC Criteria

June 12, 2007

First Posted (Estimate)

June 14, 2007

Study Record Updates

Last Update Posted (Actual)

December 7, 2017

Last Update Submitted That Met QC Criteria

December 1, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15L-CL-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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