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To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.
A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP2151 | Experimental |
| |
| ASP2151 placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP2151 | Drug | 200 mg once daily |
| |
| ASP2151 placebo |
| 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 | 8days |
| 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 moderate or severe herpes simplex, for which oral antiviral medication is indicated
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
Exclusion Criteria:
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:
Current or previous history of malignant tumor within 5 years before informed consent
Diagnosis of autoimmune disease
Evidence of bone marrow suppression
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo | Hokkaido | Japan | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | ASP2151 | 200 mg once daily |
| FG001 | ASP2151 Placebo | ASP2151 placebo once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The full analysis set (FAS). The FAS 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 |
| BG001 | ASP2151 Placebo | ASP2151 placebo 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 | The full analysis set (FAS). The FAS 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 | Number | Percentage of Participants | 8days |
|
29 days
The safety analysis population consists of 466 participants (309 in the ASP group;157 in the placebo group), excluding two participants who were randomized but never received the investigational drug.
The two excluded participants were discontinued from the study before receiving the investigational drug, and therefore, they were not monitored or assessed for adverse events.
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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 | 200 mg once daily | 128 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Genital herpes | Infections and infestations | MedDRA/J Ver. 16.0 | 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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| Drug |
once daily |
|
| 29days |
| Time to Complete Crusting | The criteria for complete crust formation are outlined as follows:
| 29days |
| 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. | 29days |
| Yokohama |
| Kanagawa |
| Japan |
| Nakano-ku | Tokyo | Japan |
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Clinical laboratory value is ineligible on day 1 |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease type | Count of Participants | Participants | No |
|
|
|
|
| Secondary | Time to Healing | The criteria for determining healing are as follows:
| The full analysis set (FAS). The FAS 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 | 29days |
|
|
|
| Secondary | Time to Complete Crusting | The criteria for complete crust formation are outlined as follows:
| The full analysis set (FAS). The FAS 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 | 29days |
|
|
|
| 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. | The full analysis set (FAS). The FAS 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 | 29days |
|
|
|
| 309 |
| 0 |
| 309 |
| 69 |
| 309 |
| EG001 | ASP2151 Placebo | ASP2151 placebo once daily | 59 | 157 | 0 | 157 | 29 | 157 |
| Nasopharyngitis | Infections and infestations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Beta-N-acetyl-D-glucosaminidase increased | Investigations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Fibrin degradation products increased | Investigations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
| Alpha 1 microglobulin increased | Investigations | MedDRA/J Ver. 16.0 | Non-systematic Assessment |
|
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |