The effectiveness and the safety of AMNV in patient with herpes zoster treated with immunosuppressive agents:exploratory Study

JRCT ID: jRCTs031190208

Registered date:13/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Herpes Zoster
• Date of first enrollment: 03/04/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Study drug (Amenamevir Tablets 200mg) Oral administration of 2 tablets (400mg) once a day after meal for 7-14 days

Outcome(s)

• Primary Outcome: Overall improvement of skin symptoms 7 days after administration

Secondary Outcome

(1) 14 days after start of administration, overall improvement of skin symptoms at the end of observation
(2) Change of skin condision where all lesions of erythemas/papulae, vesicles/pustules, erosions/ulcers and crust.
(3) Time to Complete Crusting
(4) Time to Healing
(5) Time to Pain Resolution (Pain scales: NRS)
(6) The improvement of Quality of life (QOL) (Scale:SF-8)

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients aged >= 20 years old who provide written informed consent to participation in the study.
(2) Patients who received immunosuppressive therapy (ex. Chemotherapy, oral steroid, cyclosporine, JAK inhibitor etc. ) for cancer (solid/ blood), transplantation or connective disease.
(3)Patients who appeared the rash within 5 days.

Exclude criteria

(1) Patients has a known hypersensitivity to amenamevir.
(2) Patients have been treated with Rifampicin.
(3) Patients who are not expected to have an adequate response to oral antiviral medication.
(4) Patients have been treated antiviral drugs (except for anti-influenza drugs and ophthalmic agent) or immunoglobulins within 14 days prior to the obtainment of consent.
(5) Patients who cannot interrupt everolimus,cyclosporine,sirolimus,tacrolimus during the administration of amenamevir.
(6) Patients have been received treatment to Acquired Immune Deficiency Syndrome or Human Immunodeficiency Virus.
(7) Female patients who is breastfeeding, pregnant, or plans to become pregnant during the study.
(8) Other patients who are considered to be unsuitable for the study by the investigator or subinvestigator.

Related Information

• Primary Sponsor: Imafuku Shinichi
• Source(s) of Monetary Support: Maruho Co.,Ltd.