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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029020
Receipt No. 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

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Basic information
Public title Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017
Acronym Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017
Scientific Title Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome 2017
Scientific Title:Acronym 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
1st name
Middle name
Last name Masaki Yasukawa
Organization Ehime University Hospital
Division name First Department of Internal Medicine
Zip code
Address Shitsukawa, Toon, Ehime, 791-0295, Japan
TEL 089-960-5296
Email yasukawa@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taichi Azuma
Organization Ehime University Hospital
Division name First Department of Internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 21 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000033194

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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