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NCT Number: NCT01959841

Phase III Study of ASP2151 in Herpes Zoster Patients

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.

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sapporo, Hokkaido, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

ASP2151

Drug

200 mg once daily or 400 mg once daily

Valaciclovir

Drug

1000 mg three times daily

Primary outcomes

  1. The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment

    Time frame: 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 outcomes

  1. Time to Cessation of New Lesion Formation

    Time frame: 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.

  2. Time to Complete Crusting

    Time frame: 29days

    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.

  3. Time to Healing

    Time frame: 29days

    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

  4. Time to Pain Resolution

    Time frame: 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.

  5. Time to Virus Disappearance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2013
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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