A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Immune Thrombocytopenia

PHASE2RecruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

August 28, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2026

Conditions
Immune ThrombocytopeniaTreatment
Interventions
DRUG

Obinutuzumab Injection [Gazyva]

"intravenous Obinutuzumab administration~This study adopts a prospective, single arm, open design method. 110 subjects were enrolled in the study and were treated with CD20 monoclonal antibody (Obinutuzumab: 1000mg) for once.~The first stage is the main research stage (d1-w12), which is the core treatment period. The subjects will receive intravenous infusion of 1000mg Obinutuzumab for once to observe the safety and efficacy during treatment.~The second stage (w12-w48) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Obinutuzumab after treatment."

Trial Locations (1)

300020

RECRUITING

Chinese Academy of Medical Science and Blood Disease Hospital, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER