Phase III Study of ASP2151 in Herpes Zoster Patients

Herpes Zoster Clinical Trial

Official title:

Phase III Study of ASP2151 in Herpes Zoster Patients― A Double-blind, Valaciclovir-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959841
• Other study ID #: M522101-J01
• Status: Completed
• Phase: Phase 3
• Start date: August 2013
• Est. completion date: July 10, 2015

Study information

• Verified date: October 2018
• Source: Maruho Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 751
• Est. completion date: July 10, 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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:

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:

• 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

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

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Drug:
• ASP2151
200 mg once daily or 400 mg once daily
• valaciclovir
1000 mg three times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maruho Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	29days
Secondary	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.	29days
Secondary	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	29days
Secondary	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.	29days
Secondary	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	29days