Phase III Study of ASP2151 in Herpes Zoster Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

751 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-07-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase III Study of ASP2151 in Herpes Simplex Patients

NCT01959295

Herpes Simplex

COMPLETED PHASE3

Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

NCT00487682

Herpes Zoster

COMPLETED PHASE2

Open-label Study of ASP2151 in Herpes Simplex Patients

NCT02209324

Herpes Simplex

COMPLETED PHASE3

Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food

NCT02852876

Herpes Genitalis Herpes Zoster

COMPLETED PHASE1

A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes

NCT00486200

Herpes Genitalis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Herpes Zoster

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASP2151(200 mg)

once daily

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

200 mg once daily or 400 mg once daily

ASP2151(400mg)

once daily

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

200 mg once daily or 400 mg once daily

valaciclovir

1000 mg three times daily

Group Type EXPERIMENTAL

valaciclovir

Intervention Type DRUG

1000 mg three times daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ASP2151

200 mg once daily or 400 mg once daily

Intervention Type DRUG

valaciclovir

1000 mg three times daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No