This study is an investigator-initiated, prospective, randomized, open-label, blind end-point (PROBE) phase-2 clinical trial, to preliminarily evaluate the efficacy and safety of baritinib for the treatment of acute lung injury (ALI) after spontaneous intracerebral hemorrhage (ICH). Approximately 100 patients from different geographic sites across China will be recruited and randomized to 2 parallel arms in a 1:1 ratio to the intervention arm or control arm. The study will compare early additional baritinib 4-mg once daily (QD) administration to control arm with standardized treatments (background therapy), as novel agents for ALI in aimed subjects in immunological approach; and provide cortical evidence for further phase-3 clinical trials. The trial will be across up to approximately 15-month scope (12-month enrollment period and 3-month follow-up period). One independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data in all stages to make recommendations about early study closure or changes to study protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
110
Participants will receive additional baritinib administration with 4-mg dosage once daily (QD) for consecutive 14 days after randomization (adjusted dosage of 2-mg QD for participants with eGFR between 30-60 mL/min/1.73m\^2).
The Southwest Hospital of Army Medical University
Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, China
Liaocheng People's Hospital, Liaocheng Brain Hospital
Liaocheng, Shandong, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
The score shift on the radiologic scoring system for lung injury involvement from baseline to day 14 after randomization
This radiologic scoring system for lung injury involvement was assessed with the chest CT scan, ranging from 0 to 10. The lower score indicated less lung injury while the higher represented more.
Time frame: From baseline to day 14 after randomization
The modified Rankin Scale (mRS) score at day 90 after randomization
The mRS ranged from 0 to 6 and usually was adopted for neurological assessment. The lower score indicated favorable outcome while the higher represented worse or even death.
Time frame: At day 90 after randomization
Time from randomization to the day of at least 1-point improvement on the National Institute of Allergy and Infectious Disease Ordinal Scale (NIAID-OS)
The NIAID-OS was for respiratory assessment, ranging from 1 to 8 in the original version. In this trial, the NIAID-OS was measured ranging from 3 to 8 (inclusive). The lower score indicated mild symptoms while the higher represented more critical or even death.
Time frame: From randomization to the presence of clinical end-point (NIAID-OS improvement ≥ 1 point, discharge, or death) or the end of observation (up to 90 days after randomization), whichever comes first
Peripheral blood interleukin-6 (IL-6) level at day 14 after randomization
Time frame: At day 14 after randomization
Peripheral blood interleukin-8 (IL-8) level at day 14 after randomization
Time frame: At day 14 after randomization
Peripheral blood C-reactive protein (CRP) level at day 14 after randomization
Time frame: At day 14 after randomization
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