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Ruxolitinib plus standard case in severe fever with thrombocytopenia syndrome (SFTS): a multi-center, open-label, randomized controlled study

Ruxolitinib plus standard case in severe fever with thrombocytopenia syndrome (SFTS): a multi-center, open-label, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081631
Enrollment
Unknown
Registered
2024-03-07
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-03-11

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

RUX group:Oral ruxolitinib 10 mg q12h (5 mg q12h if creatinine clearance was less than 30 ml/min) for 10 days or until discharge from the hospital with improvement (up to a maximum of 10 days),along w

Sponsors

Juxian People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following enrollment criteria to be enrolled in this study: 1. Age =18 years at the time of signing the informed consent. 2. Meet the diagnostic criteria for confirmed cases in the Guidelines for the Prevention and Treatment of Fever with Thrombocytopenia Syndrome (2010 edition). 3. have a clinical score of >8 within 6 days of the onset of the disease (total score of 18, see Table1). 4. Understand and comply with the study procedures and methods, voluntarily participate in this trial, and sign the informed consent in writing.

Exclusion criteria

Exclusion criteria: Subjects with any of the following are not eligible for enrollment in this study: 1. a prior history of rucotinib allergy; 2. women who are pregnant, planning to become pregnant or breastfeeding, or who have a positive blood/urine pregnancy test result at the time of screening 3. those who, as determined by the study physician, are likely to be alive for less than 24 hours at screening; 4. any physical or psychological disease or condition that, as determined by the study physician, is likely to increase the risk of the trial, affect the subject's compliance with the protocol, or interfere with the subject's ability to complete the trial.

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality;

Secondary

MeasureTime frame
Proportion of ICU admissions;Clinical scores dynamics;Days of hospitalization;Cost of hospitalization;Changes in laboratory indicators;

Countries

China

Contacts

Public ContactYongyuan Yao

Juxian People's Hospital

yy1982@hotmail.com+86 135 5318 4318

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026