Study of Obinutuzumab to Treat Pediatric Primary Immune Thrombocytopenia in Patients Aged 12 to 18 Who Did Not Respond to First-Line Steroid Treatment

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Obinutuzumab, an anti-CD20 monoclonal antibody, for treating pediatric primary immune thrombocytopenia ITP in patients aged 12 to 18 years who have not responded well or have relapsed after first-line glucocorticoid treatment. ITP is an autoimmune disease causing low platelet counts and bleeding, and current treatments for pediatric ITP have limited success, leading to ongoing challenges and reduced quality of life. This open, single-arm study will enroll 60 pediatric participants who will receive one intravenous infusion of 1000 mg Obinutuzumab. The study has two stages the first 12 weeks focus on treatment safety and efficacy after infusion, and the following weeks up to 48 weeks monitor ongoing safety and lasting treatment effects without additional infusions. Participants will undergo regular assessments including platelet counts, bleeding evaluations, safety monitoring, and quality of life surveys over 12 months. Researchers will measure overall treatment response, duration of response, bleeding events, recurrence rate, and health-related quality of life to understand how Obinutuzumab affects pediatric ITP. Safety will be closely observed throughout the study period.

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