Back to resultsPhase III Study of ASP2151 in Herpes Zoster Patients
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
ASP2151
valaciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Zoster
Eligibility Criteria
Inclusion Criteria:
(1) 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ASP2151(200 mg)
ASP2151(400mg)
valaciclovir
Arm Description
once daily
once daily
1000 mg three times daily
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01959841
Brief Title
Phase III Study of ASP2151 in Herpes Zoster Patients
Official Title
Phase III Study of ASP2151 in Herpes Zoster Patients- A Double-blind, Valaciclovir-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 10, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maruho Co., Ltd.
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
751 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASP2151(200 mg)
Arm Type
Experimental
Arm Description
once daily
Arm Title
ASP2151(400mg)
Arm Type
Experimental
Arm Description
once daily
Arm Title
valaciclovir
Arm Type
Experimental
Arm Description
1000 mg three times daily
Intervention Type
Drug
Intervention Name(s)
ASP2151
Intervention Description
200 mg once daily or 400 mg once daily
Intervention Type
Drug
Intervention Name(s)
valaciclovir
Intervention Description
1000 mg three times daily
Primary Outcome Measure Information:
Title
The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment
Description
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.
Time Frame
4days
Secondary Outcome Measure Information:
Title
Time to Cessation of New Lesion Formation
Description
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.
Time Frame
29days
Title
Time to Complete Crusting
Description
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.
Time Frame
29days
Title
Time to Healing
Description
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
Time Frame
29days
Title
Time to Pain Resolution
Description
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.
Time Frame
29days
Title
Time to Virus Disappearance
Description
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
Time Frame
29days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) 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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maruho Co.,Ltd. Kyoto R&D Center
Organizational Affiliation
Clinical Development Department
Official's Role
Study Director
Facility Information:
City
Sapporo
State/Province
Hokkaido
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Nakano-Ku
State/Province
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Phase III Study of ASP2151 in Herpes Zoster Patients
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