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Anti-viral

6 for Genital Herpes

Phase 2
Waitlist Available
Research Sponsored by Astellas Pharma Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 17 days
Awards & highlights

Study Summary

A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.

Eligible Conditions
  • Genital Herpes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~17 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 17 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 measures
Pharmacokinetics in study patients

Side effects data

From 2015 Phase 3 trial • 751 Patients • NCT01959841
8%
Nasopharyngitis
4%
Alpha 1 microglobulin increased
4%
Headache
3%
Fibrin degradation products increased
3%
Beta-N-acetyl-D-glucosaminidase increased
3%
Eczema
2%
Folliculitis
2%
Dermatitis contact
1%
Glucose urine present
1%
Protein urine present
100%
80%
60%
40%
20%
0%
Study treatment Arm
ASP2151(200 mg)
ASP2151(400mg)
Valaciclovir

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 6Experimental Treatment1 Intervention
Dosing regimen 4
Group II: 5Experimental Treatment1 Intervention
Dosing regimen 3
Group III: 4Experimental Treatment1 Intervention
Dosing regimen 2
Group IV: 3Experimental Treatment1 Intervention
Dosing regimen 1
Group V: 1Active Control1 Intervention
Oral administration of active comparator
Group VI: 2Placebo Group1 Intervention
Oral administration of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amenamevir
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Astellas Pharma IncLead Sponsor
692 Previous Clinical Trials
231,724 Total Patients Enrolled
Use Central ContactStudy DirectorAstellas Pharma US, Inc.
182 Previous Clinical Trials
51,809 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
2007. "A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00486200.
~39 spots leftby May 2025
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