A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes
1 other identifier
interventional
695
1 country
25
Brief Summary
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2007
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2007
CompletedFirst Posted
Study publicly available on registry
June 14, 2007
CompletedStudy Start
First participant enrolled
June 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2008
CompletedDecember 7, 2017
December 1, 2017
1.1 years
June 12, 2007
December 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
17 days
Secondary Outcomes (1)
Pharmacokinetics in study patients
4 days
Study Arms (6)
1
ACTIVE COMPARATOROral administration of active comparator
2
PLACEBO COMPARATOROral administration of placebo
3
EXPERIMENTALDosing regimen 1
4
EXPERIMENTALDosing regimen 2
5
EXPERIMENTALDosing regimen 3
6
EXPERIMENTALDosing regimen 4
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Subject is immunocompromised
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Phoenix, Arizona, 85015, United States
Unknown Facility
Tucson, Arizona, 85712, United States
Unknown Facility
Los Angeles, California, 90017, United States
Unknown Facility
Sacramento, California, 95821, United States
Unknown Facility
San Diego, California, 92108, United States
Unknown Facility
Westlake Village, California, 91361, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Boynton Beach, Florida, 33472, United States
Unknown Facility
Miami, Florida, 33156, United States
Unknown Facility
Atlanta, Georgia, 30328, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Madisonville, Kentucky, 42431, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Billings, Montana, 59101, United States
Unknown Facility
Omaha, Nebraska, 68134, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Philadelphia, Pennsylvania, 19103, United States
Unknown Facility
Arlington, Texas, 76011, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Houston, Texas, 77058, United States
Unknown Facility
Salt Lake City, Utah, 84132, United States
Unknown Facility
Annandale, Virginia, 22003, United States
Unknown Facility
Seattle, Washington, 98122, United States
Related Publications (1)
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.
PMID: 22351940BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2007
First Posted
June 14, 2007
Study Start
June 21, 2007
Primary Completion
August 12, 2008
Study Completion
August 12, 2008
Last Updated
December 7, 2017
Record last verified: 2017-12