Study of Obinutuzumab to Treat Adults with Immune Thrombocytopenia Who Did Not Respond to First-Line Therapy

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Obinutuzumab in treating immune thrombocytopenia ITP, a condition where the immune system attacks platelets causing low platelet counts and bleeding. This study focuses on adults who did not respond well or relapsed after initial treatments like corticosteroids. ITP is a challenging disease with limited effective options, and this trial aims to address the urgent need for better treatments for patients with persistent or recurring ITP. Participants will receive a single intravenous infusion of 1000 mg Obinutuzumab, a type of anti-CD20 monoclonal antibody. The study has two stages the first 12 weeks involve the core treatment and monitoring of safety and response, followed by a withdrawal period from week 12 to week 48 to observe ongoing safety and lasting effects after treatment. In total, 110 participants will be enrolled in this open-label, single-arm trial. During the study, participants will undergo regular assessments to evaluate treatment response, bleeding severity, and safety over one year. Key measures include the overall response within 12 weeks, sustained response rates at 6 and 12 months, recurrence-free survival, and safety monitoring. The study involves blood tests, physical exams, and questionnaires to track platelet counts and bleeding symptoms, ensuring close observation of the treatments effects and participant health throughout the trial period.

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