Herpes Genitalis Clinical Trial
Official title:
A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes
| Verified date | December 2017 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
| Status | Completed |
| Enrollment | 695 |
| Est. completion date | August 12, 2008 |
| Est. primary completion date | August 12, 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Pharmacokinetics in study patients | 4 days |
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