A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2026

Conditions
Immune ThrombocytopeniaTreatment
Interventions
DRUG

Obinutuzumab Injection [Gazyva]

"intravenous Obinutuzumab administration~This study adopts a prospective, single arm, open design method. 60 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)

Unknown

RECRUITING

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER