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COMPLETED
NCT06737705
PHASE2

Baricitinib for Patients With Intracerebral Hemorrhage

Sponsor: De-zhi Kang

View on ClinicalTrials.gov

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 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.

Official title: Efficacy and Safety Study of Baricitinib for Patients With Intracerebral Hemorrhage

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2025-01-01

Completion Date

2025-08-18

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

DRUG

Baritinib

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).

Locations (6)

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