Anti-CD38 Antibody Treating Pediatric Primary Immune Thrombocytopenia (ITP)

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 28, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Immune ThrombocytopeniaTreatment
Interventions
DRUG

Anti-CD38 antibody Injection

"intravenous Anti-CD38 antibody administration~This study adopts a prospective, single arm, open design method. Twenty subjects were enrolled in the study and were treated with Anti-CD38 antibody (16mg/kg/w) for 8 weeks.~The first stage is the main research stage (d1-w8), which is the core treatment period. The subjects will receive intravenous infusion of 16mg/kg Anti-CD38 antibody once a week for 8 weeks to observe the safety and efficacy during treatment.~The second stage (w9-w24) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Anti-CD38 antibody after treatment."

Trial Locations (1)

300020

RECRUITING

Chinese Academy of Medical Science and Blood Disease Hospital, Tianjin

All Listed Sponsors
collaborator

Beijing Children's Hospital

OTHER

collaborator

Tianjin Children's Hospital

OTHER

lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER