Trial · NCT01959295
Phase III Study of ASP2151 in Herpes Simplex Patients
NCT01959295, Phase 3, Completed, Maruho Co., Ltd.; results first posted 2024-10-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III Study of ASP2151 in Herpes Simplex Patients. Trials, record NCT01959295. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01959295
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study of ASP2151 in Herpes Simplex Patients
- NCT number
- NCT01959295
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 468 participants, actual
- Lead sponsor
- Maruho Co., Ltd.
- Conditions
- Herpes Simplex
- Interventions
- ASP2151, ASP2151 placebo
- First posted
- 2013-10-10
- Last updated
- 2024-10-09
- Results first posted
- 2024-10-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Healing by Day 8 | 8days | The percentage of participants achieving lesion healing by Day 8 of study treatment |
| Secondary | Time to Healing | 29days | 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 |
| Secondary | Time to Complete Crusting | 29days | 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. |
| Secondary | Time to Virus Disappearance | 29days | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Healing by Day 8 | 8days | 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. | Percentage of Participants | NUMBER |
| SECONDARY | Time to Healing | 29days | 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. | day | MEDIAN |
| SECONDARY | Time to Complete Crusting | 29days | 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. | day | MEDIAN |
| SECONDARY | Time to Virus Disappearance | 29days | 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. | day | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Healing by Day 8 | ASP2151 | 66.4 | Percentage of Participants | ||
| Percentage of Participants With Healing by Day 8 | ASP2151 Placebo | 69.5 | Percentage of Participants | ||
| Time to Healing | ASP2151 | 8 | Inter-Quartile Range 6 to 9 | day | |
| Time to Healing | ASP2151 Placebo | 8 | Inter-Quartile Range 6 to 9 | day | |
| Time to Complete Crusting | ASP2151 | 6 | Inter-Quartile Range 5 to 8 | day | |
| Time to Complete Crusting | ASP2151 Placebo | 6 | Inter-Quartile Range 5 to 8 | day | |
| Time to Virus Disappearance | ASP2151 | 4 | Inter-Quartile Range 3 to 6 | day | |
| Time to Virus Disappearance | ASP2151 Placebo | 5 | Inter-Quartile Range 4 to 6 | day |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ASP2151 | 311 | |
| Overall Study | STARTED | ASP2151 Placebo | 157 | |
| Overall Study | COMPLETED | ASP2151 | 278 | |
| Overall Study | COMPLETED | ASP2151 Placebo | 140 | |
| Overall Study | NOT COMPLETED | ASP2151 | 33 | |
| Overall Study | NOT COMPLETED | ASP2151 Placebo | 17 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Genital herpes | Infections and infestations | ASP2151 | 11 | 309 | |
| other | Genital herpes | Infections and infestations | ASP2151 Placebo | 3 | 157 | |
| other | Nasopharyngitis | Infections and infestations | ASP2151 | 15 | 309 | |
| other | Nasopharyngitis | Infections and infestations | ASP2151 Placebo | 5 | 157 | |
| other | Oral herpes | Infections and infestations | ASP2151 | 13 | 309 | |
| other | Oral herpes | Infections and infestations | ASP2151 Placebo | 8 | 157 | |
| other | Beta-N-acetyl-D-glucosaminidase increased | Investigations | ASP2151 | 9 | 309 | |
| other | Beta-N-acetyl-D-glucosaminidase increased | Investigations | ASP2151 Placebo | 2 | 157 | |
| other | Electrocardiogram QT prolonged | Investigations | ASP2151 | 3 | 309 | |
| other | Electrocardiogram QT prolonged | Investigations | ASP2151 Placebo | 4 | 157 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ASP2151 | 128 | 309 |
| Total, all-cause mortality | ASP2151 Placebo | 59 | 157 |
| Total, other adverse events | ASP2151 | 69 | 309 |
| Total, other adverse events | ASP2151 Placebo | 29 | 157 |
| Total, serious adverse events | ASP2151 | 0 | 309 |
| Total, serious adverse events | ASP2151 Placebo | 0 | 157 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ASP2151 vs ASP2151 Placebo: deaths from any cause | Trial comparisons |
| ASP2151 vs ASP2151 Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01959295
GET https://conductscience.org/api/trials/v1/NCT01959295/registered