Phase III Study of ASP2151 in Herpes Zoster Patients
1 other identifier
interventional
751
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2013
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 26, 2013
CompletedFirst Posted
Study publicly available on registry
October 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2015
CompletedResults Posted
Study results publicly available
October 18, 2018
CompletedNovember 27, 2018
October 1, 2018
1.9 years
September 26, 2013
March 22, 2018
October 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
4days
Secondary Outcomes (5)
Time to Cessation of New Lesion Formation
29days
Time to Complete Crusting
29days
Time to Healing
29days
Time to Pain Resolution
29days
Time to Virus Disappearance
29days
Study Arms (3)
ASP2151(200 mg)
EXPERIMENTALonce daily
ASP2151(400mg)
EXPERIMENTALonce daily
valaciclovir
EXPERIMENTAL1000 mg three times daily
Interventions
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maruho Co., Ltd.lead
Study Sites (3)
Unknown Facility
Sapporo, Hokkaido, Japan
Unknown Facility
Yokohama, Kanagawa, Japan
Unknown Facility
Nakano-Ku, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- linical Development Dept.
- Organization
- Maruho Co.,Ltd. Kyoto R&D Center
Study Officials
- STUDY DIRECTOR
Maruho Co.,Ltd. Kyoto R&D Center
Clinical Development Department
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2013
First Posted
October 10, 2013
Study Start
August 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 10, 2015
Last Updated
November 27, 2018
Results First Posted
October 18, 2018
Record last verified: 2018-10