UMIN-CTR Clinical Trial

Public title

Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome

Acronym

Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome

Scientific Title

Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome

Scientific Title:Acronym

Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome

Region

Japan

Condition

severe fever with thrombocytopenia syndrome

Classification by specialty

Medicine in general

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of the efficacy and safety in patients with severe fever with thrombocytopenia syndrome (SFTS) who are treated with favipiravir orally for 10-14 days.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Patient survival rate within 28 days

Key secondary outcomes

Degree of improvement of clinical manifestations

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

favipiravir is given orally for 10-14 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 9-13 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

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

25

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

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

Institute

Ehime University Hospital

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

05

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

03

Month

24

Day

Date of IRB

Anticipated trial start date

2016

Year

05

Month

23

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

05

Month

21

Day

Last modified on

2017

Year

05

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025710