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

Primary Purpose

Herpes Genitalis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ASP2151

valacyclovir

Placebo

About this trial

This is an interventional treatment trial for Herpes Genitalis focused on measuring ASP2151, Herpes Genitalis, Sexually Transmitted Disease, Herpes Simplex Virus Genital Infection, Treatment Outcome, Genital Herpes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Arm Description

Oral administration of active comparator

Oral administration of placebo

Dosing regimen 1

Dosing regimen 2

Dosing regimen 3

Dosing regimen 4

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics in study patients

Full Information

NCT ID

NCT00486200

First Posted

June 12, 2007

Last Updated

December 1, 2017

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00486200

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

June 21, 2007 (Actual)

Primary Completion Date

August 12, 2008 (Actual)

Study Completion Date

August 12, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Genitalis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

695 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Oral administration of active comparator

Arm Title

Arm Type

Placebo Comparator

Arm Description

Oral administration of placebo

Arm Title

Arm Type

Experimental

Arm Description

Dosing regimen 1

Arm Title

Arm Type

Experimental

Arm Description

Dosing regimen 2

Arm Title

Arm Type

Experimental

Arm Description

Dosing regimen 3

Arm Title

Arm Type

Experimental

Arm Description

Dosing regimen 4

Intervention Type

Drug

Intervention Name(s)

ASP2151

Intervention Description

Oral administration.

Intervention Type

Drug

Intervention Name(s)

valacyclovir

Intervention Description

Oral administration of active comparator.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral administration of placebo.

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Pharmacokinetics in study patients

Time Frame

4 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Use Central Contact

Organizational Affiliation

Astellas Pharma US, Inc.

Official's Role

Study Director

Facility Information:

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85015

Country

United States

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

City

Sacramento

State/Province

California

ZIP/Postal Code

95821

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

City

Westlake Village

State/Province

California

ZIP/Postal Code

91361

Country

United States

City

Denver

State/Province

Colorado

ZIP/Postal Code

80262

Country

United States

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33472

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33156

Country

United States

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30328

Country

United States

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

City

Arlington

State/Province

Texas

ZIP/Postal Code

76011

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84132

Country

United States

City

Annandale

State/Province

Virginia

ZIP/Postal Code

22003

Country

United States

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

22351940

Citation

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.

Results Reference

background

Links:

URL

https://astellasclinicalstudyresults.com/study.aspx?ID=231

Description

Link to results on the Astellas Clinical Study Results website.

Learn more about this trial

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

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