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 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 ICH 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
Favorable neurological outcome defined by modified Rankin Scale (mRS) score of 0-2
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
Favorable neurological outcome defined by mRS score of 0-3
Time frame: At day 90 after randomization
Shift analysis in the mRS score
Time frame: At day 90 after randomization
Peripheral blood lymphocyte count
A key measure for immunosuppression.
Time frame: At days 7 and 14 after randomization
New or exacerbated infection event
Infection is a clinical event, defined as an infection which is new or significantly exacerbated after randomization, adjudicated according to the modified CDC diagnostic criteria.
Time frame: At days 7 and 14 after randomization
Hemorrhage progression event
Hemorrhage progression is a clinical event, including hematoma expansion or postoperative cerebral rebleeding after randomization, adjudicated with criteria of the hemorrhage growth \> 6 mL or 33%, and postoperative growth ≥ 5mL or significant morphological difference in CT scans.
Time frame: At days 7 and 14 after randomization
Recurrent stroke event
A recurrent stroke is defined as an acute disturbance of focal neurologic function resulting in death or symptoms lasting more than 24 hours, including both ischemic and hemorrhagic stroke (excluding the index hemorrhage).
Time frame: At day 90 after randomization
Mortality (death event)
Mortality (death event) accounted for all-cause and is verified with medical certification or social identification system.
Time frame: At day 90 after randomization
Hierarchical composite event, including recurrent stroke and death
The hierarchical composite includes aforementioned long-term neurological events of recurrent stroke and death, which death was prioritized over recurrent stroke.
Time frame: At day 90 after randomization
Peripheral blood exploratory biomarkers
Exploratory biomarkers for evaluating immunosuppression, expressed as changes from baseline
Time frame: At days 7 and 14 after randomization
Serious adverse event (SAE) occurrence
Local-reported SAE is adjudicated if it meets the criteria according to ICH GCP E6 (R2) guideline.
Time frame: At day 90 after randomization
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