Herpes SimplexPhase 3NCT01959295

Phase III Study of ASP2151 in Herpes Simplex Patients

A Phase 3 study testing ASP2151 in people with Herpes Simplex, run by Maruho Co., Ltd. at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex. Read more about this study

Who is it for?: Ages 20 to 79 years
Conditions the study is for: Herpes Simplex
What is being tested?: ASP2151
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 468 participants
Where: 3 sitesJapan
Study dates: Aug 2013to 27 Apr 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with a rash associated with moderate or severe herpes simplex, for which oral antiviral medication is indicated
Labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
Recurrent genital herpes: Patients with at least 5 papulae or vesicles/pustules on the genital organs or in the genital and circumanal region
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

Who cannot join

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:
AST or ALT ≥ 2.5 x upper limit of normal
Platelet count < lower limit of normal

Show all 11Show fewer

Serum creatinine ≥ 1.5 mg/dL
Creatinine clearance < 30 mL/min
Current or previous history of malignant tumor within 5 years before informed consent
Diagnosis of autoimmune disease
Evidence of bone marrow suppression

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Study site
Nakano-ku, Tokyo
Study site
Sapporo, Hokkaido
Study site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: Phase III Study of ASP2151 in Herpes Simplex Patients - A Double-blind, Placebo-controlled Study -

To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.

Read the detailed description

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.

Conditions: Herpes Simplex
Being tested: ASP2151, ASP2151 placebo
Medical subject headings: Herpes Simplex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASP2151Drug
200 mg once daily
ASP2151 placeboDrug
once daily

Study groups in NCT01959295
Study group	Role	What they receive
ASP2151	Experimental	Not described Receives: Drug: ASP2151
ASP2151 placebo	Placebo comparator	Not described Receives: Drug: ASP2151 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Healing by Day 8
The percentage of participants achieving lesion healing by Day 8 of study treatment
Measured: 8days

Secondary outcomes (3)

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
Measured: 29days
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.
Measured: 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.
Measured: 29days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201327 Apr 2015

First posted10 Oct 2013 (estimated)
Study startAug 2013
Primary completionApr 2015
Study completion27 Apr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Herpes SimplexStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 468 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01959295
Sponsor's protocol ID: M522101-J11
Status last verified: Oct 2024
First submitted: 26 Sep 2013
Last updated: 9 Oct 2024
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
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Chronic Active Epstein-Barr Virus
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Natural History Study of GATA2 Deficiency and Related Disorders
GATA2 Deficiency
Not yet recruitingPhase 4
Aciclovir Versus Placebo for HSV-2 Meningitis
Herpes Simplex 2, Meningitis, Viral
Active, not recruitingPhase 1
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Genital Herpes Simplex Type 2

All Herpes Simplex trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Study of ASP2151 in Herpes Simplex Patients - A Double-blind, Placebo-controlled Study -
ClinicalTrials.gov ID: NCT01959295
Acronym / sponsor ID: M522101-J11
Conditions: Herpes Simplex
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 468 participants (actual)
Lead sponsor: Maruho Co., Ltd.Industry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Apr 2015 (actual)
Study completion: 27 Apr 2015 (actual)
First posted: 10 Oct 2013 (estimated)
Results: Posted 9 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the efficacy and safety of ASP2151 in patients with herpes simplex.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ASP2151	Experimental	Drug: ASP2151
ASP2151 placebo	Placebo comparator	Drug: ASP2151 placebo

Who may qualify

Ages: 20 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ASP2151200 mg once daily	Drug	ASP2151
ASP2151 placeboonce daily	Drug	ASP2151 placebo

Primary outcome

Percentage of Participants With Healing by Day 8
Time frame: 8days
The percentage of participants achieving lesion healing by Day 8 of study treatment

3 secondary outcomes

Time to Healing
Time frame: 29days
Time to Complete Crusting
Time frame: 29days
Time to Virus Disappearance
Time frame: 29days

Results and safety

Results posted to the registry on 9 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ASP2151	311	278
ASP2151 Placebo	157	140

Primary outcome: Percentage of Participants With Healing by Day 8

Time frame: 8days. Number. Unit: Percentage of Participants

Measure	ASP2151 n = 307	ASP2151 Placebo n = 154
Value	66.4	69.5

ASP2151 vs ASP2151 Placebo: p = 0.5086, Mantel Haenszel

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 29 days. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ASP2151	0 of 309 (0%)	69 of 309 (22.3%)	128 of 309
ASP2151 Placebo	0 of 157 (0%)	29 of 157 (18.5%)	59 of 157

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Herpes Simplex

RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingObservational study
Genetic Studies of Chronic Active Epstein-Barr Disease
Chronic Active Epstein-Barr Virus
RecruitingObservational study
Natural History Study of GATA2 Deficiency and Related Disorders
GATA2 Deficiency
Not yet recruitingPhase 4
Aciclovir Versus Placebo for HSV-2 Meningitis
Herpes Simplex 2, Meningitis, Viral
Active, not recruitingPhase 1
A Clinical Trial in Healthy Volunteers and Volunteers With Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination With an Investigational Vaccine Designed to Prevent Genital Herpes Lesions
Genital Herpes Simplex Type 2

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ASP2151 in people with Herpes Simplex, run by Maruho Co., Ltd. at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Healing by Day 8 (time frame: 8days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01959295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.