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OpenTrials
Completed

NCT Number: NCT02209324

Open-label Study of ASP2151 in Herpes Simplex Patients

A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes and Kaposi varicelliform).

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Key information

Conditions

Herpes Simplex DNA Virus Infections Herpesviridae Infections Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

16 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sapporo Hokkaido Japan, Sapporo, Japan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a rash associated with herpes simplex and a recurrent episode meeting the following criteria
  • Recurrent labial/facial herpes: Patients with at least 10 papulae or vesicles/pustules
  • Recurrent genital herpes: Patients with at least 5 papules or vesicles/pustules on the genital organs or in the genital and circumanal region
  • Kaposi varicelliform eruption: Patients with major skin symptoms of papulae or vesicles
  • Patients who can start receiving the study drug within 48 hours after onset of rash
  • Age: 16 years or older, but younger than 80 years

Exclusion criteria

  • Patients who are not expected to have an adequate response to oral antiviral medication.
  • Patients with two or more types of herpes simplex.
  • 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 < 30 mL/min
  • Current or previous history of malignant tumor within 5 years before informed consent
  • Diagnosis of autoimmune disease

Treatment and study plan

ASP2151

Drug

Other names: 200 mg once daily

Primary outcomes

  1. Percentage of Participants With Healing by Day 8

    Time frame: 8 days

    The percentage of participants achieving lesion healing by Day 8 of study treatment

Secondary outcomes

  1. Time to Healing

    Time frame: 29 days

    The criteria for determining healing are as follows:

    • A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and either the complete resolution of crusts or the complete epithelialization beneath any remaining crusts has been achieved.
    • In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas.
    • In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.

  2. Time to Complete Crusting

    Time frame: 29 days

    The criteria for complete crust formation are outlined as follows:

    • A condition where all erythematous and papular lesions, vesicular and pustular lesions, and erosive and ulcerative lesions have been resolved, and all rashes are crusted (epithelialization beneath is not required).
    • In participants where no crust has formed, a condition characterized by the epithelialization of erosions/ulcers formation in mucosal lesions and potentially other affected areas.
    • In participants where no vesicles or pustules have formed, a condition characterized by the complete resolution of all erythematous and papular lesions.

  3. Time to Virus Disappearance

    Time frame: 29 days

    The day of viral disappearance is the first day on which the results of viral isolation continuously show 'HSV negative' until the final implementation day. The negative means that the results of the isolation and culture are negative, or the isolation and culture has not been performed due to complete crusting or healing of the lesion site.

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 5, 2014
Registry last updated
Sep 27, 2024

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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