A Phase 3 interventional study of ASP2151 in Herpes Simplex, sponsored by Maruho Co., Ltd.. Completed at 3 sites in Japan. Open to participants aged 16 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-09-27.
Sponsored by Maruho Co., Ltd. · Phase 3, Interventional, and Treatment
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).
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 275 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →Maruho Co., Ltd. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria
Exclusion Criteria:
Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:
Drug: ASP2151
Also known as: 200 mg once daily
Percentage of Participants With Healing by Day 8
The percentage of participants achieving lesion healing by Day 8 of study treatment
Time frame: 8 days
Time to Healing
The criteria for determining healing are as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and either the complete resolution of crusts or the complete epithelialization beneath any remaining crusts has been achieved. 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas. 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.
Time frame: 29 days
Time to Complete Crusting
The criteria for complete crust formation are outlined as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and all rashes are crusted (epithelialization beneath is not required). 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas. 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.
Time frame: 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.
Time frame: 29 days
| Milestone | ASP2151 |
|---|---|
| Started | 275 |
| Completed | 230 |
| Not completed | 45 |
| Withdrew: Adverse event | 2 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Physician decision | 3 |
| Withdrew: Protocol violation | 14 |
| Withdrew: Withdrawal by subject | 8 |
| Withdrew: Clinical laboratory value is ineligible on day 1 | 4 |
| Withdrew: Platelet count < lln in laboratory test | 7 |
| Withdrew: Qt interval >-450 ms on measurement of an ecg | 5 |
The percentage of participants achieving lesion healing by Day 8 of study treatment
| Participants | ASP2151 |
|---|---|
| Percentage of Participants With Healing by Day 8 | 194 |
The criteria for determining healing are as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and either the complete resolution of crusts or the complete epithelialization beneath any remaining crusts has been achieved. 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas. 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.
| day | ASP2151 |
|---|---|
| Time to Healing | 7 (5 to 8) |
The criteria for complete crust formation are outlined as follows: 1. A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and all rashes are crusted (epithelialization beneath is not required). 2. In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas. 3. In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.
| day | ASP2151 |
|---|---|
| Time to Complete Crusting | 6 (5 to 8) |
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.
| day | ASP2151 |
|---|---|
| Time to Virus Disappearance | 5 (3 to 6) |
Collected over 29 days. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ASP2151 | 0/271 (0%) | 2/271 (0.7%) | 53/271 (19.6%) |
| Event | ASP2151 |
|---|---|
| Cellulitis of male external genitalorganInfections and infestations | 1/271 |
| Cervical dysplasiaReproductive system and breast disorders | 1/271 |
| Event | ASP2151 |
|---|---|
| Fibrin degradation products increasedInvestigations | 21/271 |
| Alpha 1 microglobulin increasedInvestigations | 13/271 |
| NasopharyngitisInfections and infestations | 11/271 |
| StomatitisGastrointestinal disorders | 6/271 |
| FolliculitisInfections and infestations | 6/271 |
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.
| Age, Categorical(Participants) | ASP2151 |
|---|---|
| <=18 years | 4 |
| Between 18 and 65 years | 247 |
| >=65 years | 14 |
| Age, Continuous(year) | ASP2151 |
|---|---|
| Mean | 39.2 ± 12.7 |
| Sex: Female, Male(Participants) | ASP2151 |
|---|---|
| Female | 161 |
| Male | 104 |
| Ethnicity (NIH/OMB)(Participants) | ASP2151 |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 265 |
| Race (NIH/OMB)(Participants) | ASP2151 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 265 |
| Region of Enrollment(participants) | ASP2151 |
|---|---|
| Japan | 265 |
| Disease type(Participants) | ASP2151 |
|---|---|
| Recurrent labial / facial herpes | 191 |
| Recurrent genital herpes | 39 |
| Kaposi varicelliform eruption | 35 |
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Maruho Co., Ltd.