Treatment of acyclovir-resistant herpetic keratitis by amenamevir

JRCT ID: jRCTs061190001

Registered date:17/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Epithelial herpetic keratitis
• Date of first enrollment: 01/05/2019
• Target sample size: 3
• Study type: Interventional
• Intervention(s): Amenamevir(Amenalief) 200mg (2 tablets) is orally administered once daily after breakfast for 14 days.

Outcome(s)

• Primary Outcome: Disappearance of herpetic epithelial lesion in 14 days after the start of treatment

Secondary Outcome

Efficacy evaluation: the reduction of herpetic epithelial lesion size and HSV-DNA copy number
Safety evaluation: adverse event, laboratory values (hematological test, blood biochemistry, urinalysis), vital signs, 12-lead ECG

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Men and women more than 20 years old in the timing of participation agreement
2) Patients with herpetic epithelial keratitis resistant to 2 weeks treatment by acyclovir ointment

Exclude criteria

1) Patients with allergy to amenamevir infection of bacteria or fungi
2) Pregnant or possibly pregnant women
3) Women during breast-feeding
4) Patients who were administered other experimental or investigational drugs within 3 months before the start of amenamevir
5) Patients with administration of drugs to become substrates of cytochrome P450
6) Patients with administration of drugs to inhibit cytochrome P4503A
7) Patients with administration of drugs to induce cytochrome P4503A
8) Patients with administration of drugs to become substrates of cytochrome P4502B6
9) Patients with administration of ciclosporin
10) Patients with administration of antiviral drugs
11) Patients with past history of heart diseases
12) Patients with past history of hematogenous diseases
13) Patients with severe lever diseases
14) Patients with secondary corneal or conjunctival infection of bacteria or fungi
15) Others, Patients who were decided inappropriate to this study by the primary responsible doctor

Related Information

• Primary Sponsor: Inoue Yoshitsugu