Phase III Study of ASP2151 in Herpes Simplex Patients
1 other identifier
interventional
468
1 country
3
Brief Summary
To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 26, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2015
CompletedResults Posted
Study results publicly available
October 9, 2024
CompletedOctober 9, 2024
October 1, 2024
1.7 years
September 26, 2013
February 18, 2024
October 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Healing by Day 8
The percentage of participants achieving lesion healing by Day 8 of study treatment
8days
Secondary Outcomes (3)
Time to Healing
29days
Time to Complete Crusting
29days
Time to Virus Disappearance
29days
Study Arms (2)
ASP2151
EXPERIMENTALASP2151 placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated
- Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
- Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region
- Patients who can start receiving the study drug within 48 hours after onset of rash
- Age: 20 years or older, but younger than 80 years
You may not qualify if:
- Patients who are not expected to have an adequate response to oral antiviral medication
- An extreme decline in immune function
- Presence of serious complications
- Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:
- AST or ALT ≥ 2.5 x upper limit of normal
- Platelet count \< lower limit of normal
- Serum creatinine ≥ 1.5 mg/dL
- Creatinine clearance \< 30 mL/min
- Current or previous history of malignant tumor within 5 years before informed consent
- Diagnosis of autoimmune disease
- Evidence of bone marrow suppression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maruho Co., Ltd.lead
Study Sites (3)
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Nakano-ku, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Maruho Co.,Ltd. Kyoto R&D Center
- Organization
- Clinical Development Dept.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2013
First Posted
October 10, 2013
Study Start
August 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 27, 2015
Last Updated
October 9, 2024
Results First Posted
October 9, 2024
Record last verified: 2024-10