Phase III Study of ASP2151 in Herpes Zoster Patients
- Registration Number
- NCT01959841
- Lead Sponsor
- Maruho Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 751
(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
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Patients who are not expected to have an adequate response to oral antiviral medication
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An extreme decline in immune function
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Presence of serious complications
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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
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Current or previous history of malignant tumor within 5 years before informed consent
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Diagnosis of autoimmune disease
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Evidence of bone marrow suppression
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASP2151(400mg) ASP2151 once daily ASP2151(200 mg) ASP2151 once daily valaciclovir valaciclovir 1000 mg three times daily
- Primary Outcome Measures
Name Time Method The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment 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.
- Secondary Outcome Measures
Name Time Method Time to Cessation of New Lesion Formation 29days 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 Pain Resolution 29days 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 Complete Crusting 29days We defined the following state as "Complete crusting".
1. 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).
2. In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared.Time to Virus Disappearance 29days 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 to Healing 29days We defined the following state as "Healing".
1. 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.
2. In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared