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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029020
Enrollment
10
Registered
2017-09-11
Start date
2017-09-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe fever with thrombocytopenia syndrome

Interventions

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.

Sponsors

Ehime University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Patient survival rate within 28 days

Secondary

MeasureTime frame
Degree of improvement of clinical manifestations

Countries

Japan

Contacts

Public ContactTaichi Azuma

Ehime University Hospital First Department of Internal Medicine

ataichi@m.ehime-u.ac.jp089-960-5296

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026