Herpes ZosterPhase 3NCT01959841
Phase III Study of ASP2151 in Herpes Zoster Patients
A Phase 3 study testing ASP2151 and valaciclovir in people with Herpes Zoster, run by Maruho Co., Ltd. at 3 sites in Japan.
Trial summary
To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- ASP2151 and valaciclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 751 participants
- Where
- 3 sitesJapan
- Study dates
- Aug 2013to 10 Jul 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 who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash
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 < 50 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
About this study
Official title: Phase III Study of ASP2151 in Herpes Zoster Patients- A Double-blind, Valaciclovir-controlled Study
To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.
Read the detailed description
A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving cessation of new lesion formation by Day 4 of study treatment" to demonstrate the non-inferiority of ASP2151 to VACV. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.
- Conditions
- Herpes Zoster
- Being tested
- ASP2151, valaciclovir
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP2151Drug
200 mg once daily or 400 mg once daily
valaciclovirDrug
1000 mg three times daily
| Study group | Role | What they receive |
|---|---|---|
| ASP2151(200 mg) | Experimental | once daily Receives: Drug: ASP2151 |
| ASP2151(400mg) | Experimental | once daily Receives: Drug: ASP2151 |
| valaciclovir | Experimental | 1000 mg three times daily Receives: Drug: valaciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment
The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The "new lesion formation" was defined as the state in which the number of rashes is increasing.
Measured: 4days
Secondary outcomes (5)
Time to Cessation of New Lesion Formation
The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The "new lesion formation" was defined as the state in which the number of rashes is increasing.
Measured: 29days
Time to Complete Crusting
We defined the following state as "Complete crusting".
- A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and all rashes are crusted (epithelialization of the base of crusts is not required).
- In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared.
Measured: 29days
Time to Healing
We defined the following state as "Healing".
- A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and complete disappearance of crusts or complete epithelialization of the base of crusts are considered to have been achieved.
- In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared
Measured: 29days
Time to Pain Resolution
Investigators assessed the pain using NRS. The date of pain resolution is defined as the first day when all NRS scores are rated as 2 or less, and such scores are continuously observed until Day 92 or discontinuation visit.
Measured: 29days
Time to Virus Disappearance
Virus desiappearance was defined as the participants who who reached virus-negative status according to the virus isolation and culture assay or whose samples were not available because of complete crusting or healing
Measured: 29days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2015
- Study completion10 Jul 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 ZosterStudies 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
- 751 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maruho Co.,Ltd. Kyoto R&D Center, Study director, Clinical Development Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01959841
- Sponsor's protocol ID
- M522101-J01
- Status last verified
- Oct 2018
- First submitted
- 26 Sep 2013
- Last updated
- 27 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of ASP2151 in Herpes Zoster Patients- A Double-blind, Valaciclovir-controlled Study
- ClinicalTrials.gov ID
- NCT01959841
- Acronym / sponsor ID
- M522101-J01
- Conditions
- Herpes Zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 751 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- 10 Jul 2015 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Posted 18 Oct 2018
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 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.
Detailed description
A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving cessation of new lesion formation by Day 4 of study treatment" to demonstrate the non-inferiority of ASP2151 to VACV. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASP2151(200 mg) | Experimental | Drug: ASP2151once daily |
| ASP2151(400mg) | Experimental | Drug: ASP2151once daily |
| valaciclovir | Experimental | Drug: valaciclovir1000 mg three times daily |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash
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 or 400 mg once daily | Drug | ASP2151(200 mg), ASP2151(400mg) |
| valaciclovir1000 mg three times daily | Drug | valaciclovir |
Primary outcome
The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment
Time frame: 4days
The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The "new lesion formation" was defined as the state in which the number of rashes is increasing.
5 secondary outcomes
Time to Cessation of New Lesion Formation
Time frame: 29days
Time to Complete Crusting
Time frame: 29days
Time to Healing
Time frame: 29days
Time to Pain Resolution
Time frame: 29days
Time to Virus Disappearance
Time frame: 29days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Maruho Co.,Ltd. Kyoto R&D Center study director
Clinical Development Department
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 and valaciclovir in people with Herpes Zoster, 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 1 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 27 Nov 2018. 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. 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 18 Oct 2018). 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?
The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment (time frame: 4days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2018.