UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017
Title of the study (Brief title)	Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017
Region	Japan

Condition
Condition	severe fever with thrombocytopenia syndrome
Classification by specialty	Medicine in general Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient survival rate within 28 days
Key secondary outcomes	Degree of improvement of clinical manifestations

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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
Key exclusion criteria	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
Target sample size	10

Research contact person
Name of lead principal investigator	Masaki Yasukawa
Organization	Ehime University Hospital
Division name	First Department of Internal Medicine
Address	Shitsukawa, Toon, Ehime, 791-0295, Japan
TEL	089-960-5296
Email	yasukawa@m.ehime-u.ac.jp

Public contact
Name of contact person	Taichi Azuma
Organization	Ehime University Hospital
Division name	First Department of Internal Medicine
Address	Shitsukawa, Toon, Ehime, 791-0295, Japan
TEL	089-960-5296
Homepage URL
Email	ataichi@m.ehime-u.ac.jp

Sponsor
Institute	Ehime University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 21 Day
Anticipated trial start date	2017 Year 09 Month 11 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 06 Day
Last modified on	2019 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033194