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A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Immune Thrombocytopenia
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Summary
To evaluate the safety and efficacy of Obinutuzumab in the treatment of immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line treatment.
Official title: A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-Human CD20 Monoclonal Antibody Obinutuzumab in the Treatment of Primary Immune Thrombocytopenia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2023-08-28
Completion Date
2026-08
Last Updated
2025-02-21
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, China