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

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

24

A total of 24 patients were enrolled in the study upon their informed consent. The study consisted of 10 males (41.7%) and 14 females (58.3%), with a mean age of 66.4 +- 12.0 years. The time from the onset of herpes zoster to the start of administration of amenamevir (AMNV) was 3.3 +- 1.1 days, and the most common sites of herpes zoster were the thoracic back (9 cases, 37.5%), abdominal back (6 cases, 25.0%), and lumbar buttocks (7 cases, 29.2%). Malignant tumors (12 cases, 50.0%) were the most common cause of patients' immunosuppression and oral steroid therapy (12 cases, 50.0%) and chemotherapy (10 cases, 41.7%) were the most common interventions for the diseases that caused immunosuppression.

Registration Period: From March 2020 to December 2021 Number of enrolled patients per month March 2020: 0, April 2020: 1 May 2020: 0, June 2020: 0 July 2020: 1, August 2020: 0 September 2020: 1, October 2020: 1 November 2020: 1, December 2020: 0 January 2021: 1, February 2021: 1 March 2021: 1, April 2021: 0 May 2021: 1, June 2021: 5 July 2021: 3, August 2021: 4 September 2021: 3, October 2021: 0 November 2021: 0, December 2021: 0

A total of 22 Adverse events (AE) in 11 cases were reported. Hyponatremia was observed in 2 cases (8.3%) and other 20 AEs in 1 case each (4.2%). Of these, 5 AEs (bacterial skin infection, anemia, hyponatremia, headache, and liver function abnormality) in 1 patient were regarded as causally related to AMNV. 2 SAEs (bacterial skin infection and cancer pain) in 2 patients were reported. Among which 1 SAE (bacterial skin infection) had a causal relationship with AMNV that could not be ruled out.

As the primary endpoint, the overall improvement of skin symptoms at 7 days administration of AMNV was 58.3% (14 of 24 cases)for "marked improvement", 20.8% (5 of 24 cases) for "improvement," and combined improvement rate of 79.2% (95% confidence interval: [57.8, 92.9]). The improvement rate at 14 days administration of AMNV was 95.7% and the overall improvement of skin symptoms at 28 days administration was judged as "markedly improved" in all cases, indicating that skin symptoms had been improved. The skin symptoms showed that crusting peaked 7 days administration, indicating that the skin symptoms were moving toward a normal state. Regarding the number of days to crusts cleared and healing, half of the cases were shown to be crusts cleared and healing by 14 days administration. For SF-8 scores, improvement of scores in general health was observed at 7 days administration, and improvement of scores in vitality was observed at 14 days. Body pain and Role emotional scores also showed improvement at 28 days administration. Summary scores for physical health showed improvement from 7 days administration, but those for mental health showed no change.

24 patients with herpes zoster and moderate to severe skin rashes for which immunosuppressive drugs were prescribed were treated by AMNV. 19 of the 24 patients showed overall improvement after 7 days of treatment. Recovery of herpes zoster was observed based on healing time, and no safety concerns were noted, although 5 adverse reactions were noted in one patient. AMNV is thought to be useful for patients with herpes zoster who are being treated with cancer or other diseases on immunosuppressive drugs.

June. 30, 2024

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs031190208

Imafuku Shinichi

Fukuoka University Hospital

7-45-1 Nanakuma, Jonan-ku, Fukuoka

dermatologist@mac.com

Imafuku Shinichi

Fukuoka University Hospital

7-45-1 Nanakuma, Jonan-ku, Fukuoka

+81-92-801-1011

dermatologist@mac.com

Complete

Feb. 13, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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.

Both

Herpes Zoster

Study drug (Amenamevir Tablets 200mg) Oral administration of 2 tablets (400mg) once a day after meal for 7-14 days

Overall improvement of skin symptoms 7 days after administration

(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)

+81-3-3265-4804

Jan. 10, 2020

none