Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-02-01 @ 10:42 PM
Study NCT ID:
NCT01959295
Status:
COMPLETED
Last Update Posted:
2024-10-09
First Post:
2013-09-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Study of ASP2151 in Herpes Simplex Patients
Sponsor:
Maruho Co., Ltd.
Organization:
Study Overview
Official Title:
Phase III Study of ASP2151 in Herpes Simplex Patients - A Double-blind, Placebo-controlled Study -
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.
Detailed Description:
A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: