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

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Herpes Genitalis

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

Phase: Phase 2

Status: Completed

Sponsored by: Astellas Pharma Inc

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

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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

Eligibility

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

Locations and Contacts

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

Additional Information

Link to results on JAPIC

Related 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.

Starting date: June 2007
Last updated: February 27, 2013

Page last updated: August 23, 2015

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