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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP2151 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP2151 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Healing by Day 8 | The percentage of participants achieving lesion healing by Day 8 of study treatment | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Healing | The criteria for determining healing are as follows:
|
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Inclusion Criteria:
Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria
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
Exclusion Criteria:
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:
Current or previous history of malignant tumor within 5 years before informed consent
Diagnosis of autoimmune disease
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo Hokkaido Japan | Sapporo | Japan | ||||
| Oota-ku Tokyo Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | ASP2151 | 200mg once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Efficacy analysis set was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | ASP2151 | 200mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Healing by Day 8 | The percentage of participants achieving lesion healing by Day 8 of study treatment | Efficacy analysis set was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration. | Posted | Count of Participants | Participants | 8 days |
|
|
29 days
The safety analysis population consisted of 271 participants, excluding four participants who were registered but never received the investigational drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ASP2151 | 200mg once daily | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis of male external genitalorgan | Infections and infestations | MedDRA/J Ver. 16.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomatitis | Gastrointestinal disorders | MedDRA/J Ver. 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maruho Co.,Ltd. Kyoto R&D Center | Clinical Development Dept. | +81-75-325-3255 | ctinfo@mii.maruho.co.jp |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C568714 | ASP2151 |
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| 29 days |
| Time to Complete Crusting | The criteria for complete crust formation are outlined as follows:
| 29 days |
| Time to Virus Disappearance | The day of viral disappearance is the first day on which the results of viral isolation continuously show 'HSV negative' until the final implementation day. The negative means that the results of the isolation and culture are negative, or the isolation and culture has not been performed due to complete crusting or healing of the lesion site. | 29 days |
| Tokyo |
| Japan |
| Yokohama Kanagawa Japan | Yokohama | Japan |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Clinical laboratory value is ineligible on day 1 |
|
| Platelet count < LLN in Laboratory test |
|
| QT interval >-450 ms on measurement of an ECG |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease type | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Time to Healing | The criteria for determining healing are as follows:
| Efficacy analysis set was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration. | Posted | Median | Inter-Quartile Range | day | 29 days |
|
|
|
| Secondary | Time to Complete Crusting | The criteria for complete crust formation are outlined as follows:
| Efficacy analysis set was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration. | Posted | Median | Inter-Quartile Range | day | 29 days |
|
|
|
| Secondary | Time to Virus Disappearance | The day of viral disappearance is the first day on which the results of viral isolation continuously show 'HSV negative' until the final implementation day. The negative means that the results of the isolation and culture are negative, or the isolation and culture has not been performed due to complete crusting or healing of the lesion site. | Efficacy analysis set was defined as patients who were diagnosed with labial/facial herpes or recurrent genital herpes at the time of case registration, subsequently received the study drug at least once, and had any efficacy variable measured, except for those found not to have herpes simplex after study drug administration. | Posted | Median | Inter-Quartile Range | day | 29 days |
|
|
|
| 271 |
| 2 |
| 271 |
| 53 |
| 271 |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA/J Ver. 16.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA/J Ver. 16.1 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA/J Ver. 16.1 | Non-systematic Assessment |
|
| Fibrin degradation products increased | Investigations | MedDRA/J Ver. 16.1 | Non-systematic Assessment |
|
| Alpha 1 microglobulin increased | Investigations | MedDRA/J Ver. 16.1 | Non-systematic Assessment |
|
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |