Phase 3 Study of ASP2151 in Herpes Zoster Patients - A Double-blind,Valaciclovir-controlled Study
- Conditions
- herpes zoster
- Registration Number
- JPRN-jRCT2080222242
- Lead Sponsor
- Maruho Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 750
(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
(1) Patients who are not expected to have an adequate response to oral antiviral medication
(2) An extreme decline in immune function
(3) Presence of serious complications
(4) Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent:
1) AST or ALT >= 2.5 x upper limit of normal
2) Platelet count < lower limit of normal
3) Serum creatinine >= 1.5 mg/dL
4) Creatinine clearance < 50 mL/min
(5) Current or previous history of malignant tumor within 5 years before informed consent
(6) Diagnosis of autoimmune disease
(7) Evidence of bone marrow suppression
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method