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

Condition(s) targeted: Herpes Genitalis

Intervention: ASP2151 (Drug); valacyclovir (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.

Overall contact:
Astellas Pharma US Medical Information, Phone: 800-727-7003, Email: clintrials.info@us.astellas.com

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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: Pharmacokinetics in study patients

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Astellas Pharma US Medical Information, Phone: 800-727-7003, Email: clintrials.info@us.astellas.com

Birmingham, Alabama 35294, United States; Recruiting
Central Contact

Tucson, Arizona 85712, United States; Recruiting
Central Contact

Phoenix, Arizona 85015, United States; Recruiting

San Diego, California 92108, United States; Recruiting
Central Contact

Westlake Village, California 91361, United States; Recruiting
Central Contact

Carmichael, California 95608, United States; Recruiting
Central Contact

Los Angeles, California 90017, United States; Recruiting

Denver, Colorado 80045, United States; Recruiting
Central Contact

Miami, Florida 33156, United States; Recruiting
Central Contact

Boynton Beach, Florida 33472, United States; Recruiting

Atlanta, Georgia 30328, United States; Recruiting
Central Contact

Chicago, Illinois 60612, United States; Withdrawn

Indianapolis, Indiana 46202, United States; Recruiting

Madisonville, Kentucky 42431, United States; Terminated

Baltimore, Maryland 21201, United States; Recruiting

Billings, Montana 59101, United States; Recruiting

Omaha, Nebraska 68134, United States; Recruiting

Albuquerque, New Mexico 87131, United States; Recruiting
Central Contact

Portland, Oregon 97210, United States; Recruiting
Central Contact

Philadelphia, Pennsylvania 19103, United States; Recruiting

Houston, Texas 77030, United States; Recruiting

Houston, Texas 77058, United States; Recruiting

Arlington, Texas 76011, United States; Recruiting
Central Contact

Salt Lake City, Utah 84132, United States; Recruiting
Central Contact

Annandale, Virginia 22003, United States; Recruiting
Central Contact

Seattle, Washington 98122, United States; Recruiting
Central Contact

Starting date: June 2007
Ending date: September 2008
Last updated: April 14, 2008