Baricitinib for Respiratory Injury in Patients With Intracerebral Hemorrhage (NCT06737705) | Clinical Trial Compass
CompletedPhase 2
Baricitinib for Respiratory Injury in Patients With Intracerebral Hemorrhage
China110 participantsStarted 2025-01-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Participant (or legally authorized representative) who gives informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol;
✓. Are male or female patients from 18 years of age (inclusive), at the time of enrollment;
✓. Have acute, spontaneous, primary, supratentorial intracerebral hemorrhage (ICH), confirmed by head CT scan, at the time of enrollment;
✓. Complicated with acute lung injury (ALI), confirmed by chest CT scan, at the time of enrollment.
Exclusion criteria
✕. Have cerebellar or brainstem ICH;
✕. Have secondary ICH due to known or suspected structural abnormality in the brain, i.e., trauma, aneurysm, arteriovenous malformation, tumor;
✕. Have severe cerebral comorbidities, i.e., historical severe stroke, hydrocephalus, epilepsy;
✕. Have known advanced dementia or significant pre-stroke disability (modified Rankin Scale score of \> 1);
What they're measuring
1
The score shift on the radiologic scoring system for lung injury involvement from baseline to day 14 after randomization
Timeframe: From baseline to day 14 after randomization
. Have comorbidities might result in ALI, i.e., interstitial lung disease, chronic obstructive pulmonary disease, lung tumor, asthma, chronic respiratory failure, chronic heart failure;
✕. Have severe immunosuppression, defined as neutropenia (absolute neutrophil count \< 1.0×10\^9 cells/L) or lymphopenia (absolute lymphocyte count \< 0.2×10\^9 cells/L);
✕. Have ever received attenuated live vaccination or immunological treatments (see below) within 4 weeks prior to the enrollment, or intend to receive measures above;