The effectiveness and the safety of AMNV in patient with herpes zoster treated with immunosuppressive agents:exploratory Study (SAPPHIRE study)
- Conditions
- Herpes Zoster
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
(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.
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method - Overall improvement of skin symptoms 7 days after administration
- Secondary Outcome Measures
Name Time Method overall improvement of skin symptoms 14 days after start of administration overall improvement of skin symptoms at the end of observation
Change of skin condition Change of skin condition where all lesions of erythemas/papulae, vesicles/pustules, erosions/ulcers and crust
Time to Pain Resolution Pain scales: NRS
The improvement of Quality of life (QOL) Scale:SF-8