Trial intelligence / Profile preview

ASP2151 in Herpes Simplex

NCT01959295Phase 3

Key facts

Status
Completed
Start
Aug 2013
Primary completion
Apr 2015
Countries
1
Modality
Small Molecules
Conditions
herpes simplex (HSV)
01

Overview

Phase 3, randomised, double-blind trial in herpes simplex (HSV) comparing ASP2151 with Placebo (2 arms). Primary endpoint: Percentage of Participants With Healing by Day 8. Started Aug 2013; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • ASP2151

    Amenamevir 200 mg once daily

  • Placebo

    Placebo once daily

03

Who it enrols

Adult patients (20-79 years) with moderate to severe recurrent herpes simplex (labial/facial or genital) who can start treatment within 48 hours of rash onset. Patients with significant renal, hepatic, or immune impairment are excluded.

04

Endpoints

Primary

  • Percentage of Participants With Healing by Day 8

Secondary

  • Time to Healing

  • Time to Complete Crusting

  • Time to Virus Disappearance

05

Results

Not all primary endpoints met

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