Recurrent Herpes Simplex (recurrent herpes labialis and recurrent genital herpes)
Conditions
Interventions
investigational material(s)
Generic name etc : AK-120
INN of investigational material : Famciclovir
Therapeutic category code : 625 Anti-virus agents
Dosage and Administration for Investigational mate
Sponsors
Maruho Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with Recurrent Herpes Simplex
Exclusion criteria
Exclusion criteria: (1)Patients diagnosed with immunodeficiency or immunocompromised function (such as patients with congenital immunodeficiency, AIDS patients, patients with HIV infection) (2)Patients who have received organ transplants or bone marrow transplants (3)Patients with a history of renal impairment, patients with potential renal impairment, or patients with renal impairment (4)Patients with any disorders that should not be enrolled in the study such as; -severe cardiac disorders -severe hepatic disorders -severe pulmonary disorders -severe gastrointestinal disorders -severe blood disorders (5)Pregnant women, women who may be pregnant, lactating women or women who wish to become pregnant or women who are unwilling to use a suitable method of contraception as directed by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| exploratory efficacy Time to healing of all herpes simplex lesions The principal investigator or sub-investigator will observe all lesional sites at each evaluation time point to assess whether the lesions have healed and if so, the time and date of healing is determined. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy (1)Time to cessation of viral shedding at the herpes simplex lesions (1)First viral sampling date and time that all subsequent viral cultures are confirmed as negative, or first consultation date and time that viral sampling is not possible because of crusting or epithelialization. efficacy (2)Time to complete crusting of all herpes simplex lesions (2)The principal investigator or sub-investigator will observe all lesional sites at each evaluation time point to assess whether all lesions have crusted and if so, the time and date of full crusting is determined. | — |
Countries
Japan
Outcome results
None listed