Open-label Study of ASP2151 in Herpes Simplex Patients
1 other identifier
interventional
275
1 country
3
Brief Summary
A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes and Kaposi varicelliform).
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 Nov 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
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 31, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2015
CompletedResults Posted
Study results publicly available
September 27, 2024
CompletedSeptember 27, 2024
February 1, 2024
1.7 years
July 31, 2014
February 18, 2024
September 23, 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
8 days
Secondary Outcomes (3)
Time to Healing
29 days
Time to Complete Crusting
29 days
Time to Virus Disappearance
29 days
Study Arms (1)
ASP2151
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria
- Recurrent labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
- Recurrent genital herpes: Patients with at least 5 papules or vesicles/pustules on the genital organs or in the genital and circumanal region
- Kaposi varicelliform eruption: Patients with major skin symptoms of papulae or vesicles
- Patients who can start receiving the study drug within 48 hours after onset of rash
- Age: 16 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.
- Patients with two or more types of herpes simplex.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maruho Co., Ltd.lead
Study Sites (3)
Sapporo Hokkaido Japan
Sapporo, Japan
Oota-ku Tokyo Japan
Tokyo, Japan
Yokohama Kanagawa Japan
Yokohama, 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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2014
First Posted
August 5, 2014
Study Start
November 1, 2013
Primary Completion
July 1, 2015
Study Completion
August 20, 2015
Last Updated
September 27, 2024
Results First Posted
September 27, 2024
Record last verified: 2024-02