Unique ID issued by UMIN | UMIN000029020 |
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Receipt number | R000033194 |
Scientific Title | Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017 |
Date of disclosure of the study information | 2017/09/11 |
Last modified on | 2019/03/10 11:49:49 |
Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017
Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017
Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017
Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017
Japan |
severe fever with thrombocytopenia syndrome
Medicine in general | Infectious disease |
Others
NO
Evaluation of the efficacy and safety in patients with severe fever with thrombocytopenia syndrome (SFTS) who are treated with favipiravir orally for 7-14 days
Safety,Efficacy
Patient survival rate within 28 days
Degree of improvement of clinical manifestations
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Favipiravir is given orally for 7-14 d, at the dose of 1,800 mg twice a day on the first day and of 800 mg twice a day for the subsequent 6-13 d.
16 | years-old | <= |
Not applicable |
Male and Female
1. Patients who meet criteria of following 1) or 2) at the time of the registration
1) Patients who are revealed SFTS-virus (SFTSV) in their peripheral blood infection confirmed by RT-PCR
2) Patients who have crust formations causing by tick bite and highly suspected as having SFTSV infection in reference to the following conditions
(1) A Fever over 38 degrees
(2) Thrombocytopenia (less than 100,000/mm3)
(3) Leukocytopenia (less than 4,000/mm3)
(4) Digestive organ symptoms (nausea, vomiting, abdominal pain, diarrhea, melena, etc.)
2. Patients whose written informed consent could be obtained
1. Patients who are revealed of SFTSV load decreasing or had improvements of clinical manifestation
2. Patients who had been running fever while seven or more days
3. Patients who are treated for severe hepatic disease (Child-Pugh grade C)
4. Pregnant women or patients who might be pregnant
5. Patients who have difficulty in taking the extremely effective contraception during the first day of treatment with favipiravir until 7days after the medication
6. Patients who suffer from hereditary xanthinuria
7. Patients who have hypouriceia (less than 1mg/dl) or had been made a diagnosis of urinary tract xanthine calculus
8. Patients who have a history of hyper sensitivity for favipiravir
9. Patients who are inadequate for enrollment for this protocol with the investigator's judgment
10
1st name | |
Middle name | |
Last name | Masaki Yasukawa |
Ehime University Hospital
First Department of Internal Medicine
Shitsukawa, Toon, Ehime, 791-0295, Japan
089-960-5296
yasukawa@m.ehime-u.ac.jp
1st name | |
Middle name | |
Last name | Taichi Azuma |
Ehime University Hospital
First Department of Internal Medicine
Shitsukawa, Toon, Ehime, 791-0295, Japan
089-960-5296
ataichi@m.ehime-u.ac.jp
Ehime University Hospital
Japan Agency for Medical Research and Development
Japanese Governmental office
NO
2017 | Year | 09 | Month | 11 | Day |
Unpublished
Completed
2017 | Year | 08 | Month | 21 | Day |
2017 | Year | 09 | Month | 11 | Day |
2019 | Year | 12 | Month | 31 | Day |
2017 | Year | 09 | Month | 06 | Day |
2019 | Year | 03 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033194
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