Herpes Simplex
Conditions
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).
Interventions
DRUGASP2151
Sponsors
Maruho Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Patients who can start receiving the study drug within 48 hours after onset of rash 3. Age: 16 years or older, but younger than 80 years
Exclusion criteria
1. Patients who are not expected to have an adequate response to oral antiviral medication. 2. Patients with two or more types of herpes simplex. 3. An extreme decline in immune function 4. Presence of serious complications 5. 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 6. Current or previous history of malignant tumor within 5 years before informed consent 7. Diagnosis of autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Healing by Day 8 | 8 days | The percentage of participants achieving lesion healing by Day 8 of study treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Healing | 29 days | 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 to Complete Crusting | 29 days | 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 to Virus Disappearance | 29 days | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ASP2151 200mg once daily | 265 |
| Total | 265 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Clinical laboratory value is ineligible on day 1 | 4 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Platelet count < LLN in Laboratory test | 7 |
| Overall Study | Protocol Violation | 14 |
| Overall Study | QT interval >-450 ms on measurement of an ECG | 5 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | ASP2151 |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 247 Participants |
| Age, Continuous | 39.2 year STANDARD_DEVIATION 12.7 |
| Disease type Kaposi varicelliform eruption | 35 Participants |
| Disease type Recurrent genital herpes | 39 Participants |
| Disease type Recurrent labial / facial herpes | 191 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 265 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 265 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Japan | 265 participants |
| Sex: Female, Male Female | 161 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 271 |
| other Total, other adverse events | 53 / 271 |
| serious Total, serious adverse events | 2 / 271 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ASP2151 | Percentage of Participants With Healing by Day 8 | 194 Participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASP2151 | Time to Complete Crusting | 6 day |
Secondary
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
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASP2151 | Time to Healing | 7 day |
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.
Time frame: 29 days
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ASP2151 | Time to Virus Disappearance | 5 day |