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Post-marketing clinical study of AVIGAN tablets 200mg - Severe Fever with Thrombocytopenia Syndrome -

Post-marketing clinical study of AVIGAN tablets 200mg (SFTS)

PMS Management Supervisor

FUJIFILM Toyama Chemical Co., Ltd.

2-14-1, Kyobashi, Chuo-ku, Tokyo, Japan

tc-avg@fujifilm.com

Manager of Postmarketing surveillance

FUJIFILM Toyama Chemical Co., Ltd.

2-14-1, Kyobashi, Chuo-ku, Tokyo, Japan

+81-3-5579-5768

tc-avg@fujifilm.com

Recruiting

Dec. 17, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Patients reported to be positive for SFTSV in an RT-PCR test
(2) Patients within 7 days of the onset of symptoms (Fever, fatigue, headache, etc.) at the start of study treatment
(3) Age: >= 18 to < 80 years old (at the time of consent)
(4) Sex: Irrespective
(5) Outpatient/hospitalization: Hospitalization
(6) Patients from whom written informed consent can be obtained from the patients themselves.

(1) Patients suspected of having concurrent serious bacterial infection, as indicated by increased procalcitonin levels, increased C-reactive protein levels, positive blood cultures before the start of Avigan tablets administration.
(2) Patients suspected of having concurrent serious fungal infection, as indicated by abnormal (1,3)-beta-D-glucan levels before the start of Avigan tablets administration.
(3) Patients tested positive for SARS-CoV-2 or influenza virus by nucleic acid detection test or antigen test using airway sample before the start of Avigan tablets administration.
(4) Patients with life-threatening serious complications, as indicated by cardiac dysfunction/Myocarditis, Rhabdomyolysis before the start of Avigan tablets administration.
(5) Patients with complications of an immunodeficiency disorder, such as acquired immunodeficiency syndrome (AIDS), or patients using immunosuppressants (excluding adrenocorticosteroids)
(6) Patients with severe renal impairment (CLcr < 30 mL/min) or for whom dialysis is performed regularly CLcr estimated value (mL/min) will be calculated using Cockcroft-Gault formula.
Male: [(140 - age in years) x body weight (kg)] / [72 x serum creatinine (mg/dL)]
Female: [0.85 x (140 - age in years) x body weight (kg)] / [72 x serum creatinine (mg/dL)]
(7) Patients with severe hepatic dysfunction (equivalent to Grade C in the Child-Pugh classification)
(8) Patients with advanced or terminal cancer who may not complete post-marketing clinical trials.
(9) Patients with a tendency for improvement in symptoms before the start of Avigan tablets administration.
(10) Patients for whom oral administration of favipiravir with tablet is difficult, as indicated by consciousness disturbed (score 3 or more of Score classification by clinical symptoms and findings before the start of Avigan tablets administration.
(11) Patients who have already been administered Avigan tablets for this episode of SFTS
(12) Patients who are pregnant or possibly pregnant
(13) Patients tested positive for pregnancy before the start of Avigan tablets administration.
(14) Lactating patients
(15) Patients who find it difficult to use effective contraceptive method (such as condoms,oral contraceptives, intrauterine systems (IUS), intrauterine devices (IUD), etc.) with their partner during the Avigan tablet administration periods and for 10 days after discontrinuation.
(16) Patients with a history of gout or patients who are currently being treated for gout or hyperuricemia
(17) Patients with hereditary xanthinuria
(18) Patients who have been diagnosed with hypouricemia (less than 1 mg/dL) or xanthine urinary calculus
(19) Patients deemed ineligible by the attending or collaborating physicians due to difficulties with frequent blood sampling or other reasons.

Both

Severe Fever with Thrombocytopenia Syndrome

To be orally administered twice daily.
On Day 1, nine the Avigan tablets (200) are to be taken twice, and on Days 2 to 10, four the Avigan tablets (200) are to be taken twice, at 12-hour intervals, to the extent possible. If the first dose on Day 1 is administered at night, the second dose should be taken after an interval of at least 4 hours, considering the blood half-life of favipiravir.

SFTSV genome load

(1) Clinical symptoms and findings (vomiting, diarrhea, impaired consciousness and the clinical status)
(2) Cumulative mortality up to Day 28
(3) Virus neutralizing antibody titer

Nov. 27, 2024

No

none