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Open-label Study of ASP2151 in Herpes Simplex Patients

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ClinicalTrials.gov Identifier: NCT02209324
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Herpes Simplex Drug: ASP2151 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Study of ASP2151 in Herpes Simplex Patients
Study Start Date : November 2013
Actual Primary Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Herpes Simplex

Arm Intervention/treatment
Experimental: ASP2151 Drug: ASP2151
Other Name: 200 mg once daily




Primary Outcome Measures :
  1. The proportion of subjects achieving lesion healing by Day 8 of study treatment [ Time Frame: 8 days ]

Secondary Outcome Measures :
  1. Time to healing [ Time Frame: 29 days ]
  2. Time to complete crusting [ Time Frame: 29 days ]
  3. Time to virus disappearance [ Time Frame: 29 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 79 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Patients who can start receiving the study drug within 48 hours after onset of rash
  3. Age: 16 years or older, but younger than 80 years

Exclusion Criteria:

  1. Patients who are not expected to have an adequate response to oral antiviral medication.
  2. Patients with two or more types of herpes simplex.
  3. An extreme decline in immune function
  4. Presence of serious complications
  5. 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
  6. Current or previous history of malignant tumor within 5 years before informed consent
  7. Diagnosis of autoimmune disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209324


Locations
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Japan
Sapporo Hokkaido Japan
Sapporo, Japan
Oota-ku Tokyo Japan
Tokyo, Japan
Yokohama Kanagawa Japan
Yokohama, Japan
Sponsors and Collaborators
Maruho Co., Ltd.

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT02209324     History of Changes
Other Study ID Numbers: M522101-J12
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases