UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022398
Receipt number R000025710
Scientific Title Clinical study of favipiravir for patients with severe fever with thrombocytopenia syndrome
Date of disclosure of the study information 2016/05/24
Last modified on 2017/05/23 12:44:59

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Basic information

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

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 10-14 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 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



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

25


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 or person

Institute

Ehime University Hospital

Institute

Department

Personal name



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

2016 Year 05 Month 24 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name