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
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