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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 and above, male or female

• Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)

• Diagnosis of ITP ≥3 months, and with a platelet count of \<30 X 109/L measured within 2 days prior to administration(Platelet counts were measured at least 2 times during screening (at least 1 week apart) with platelets\<30 X 109/L)

• Failure to achieve response or relapse after corticosteroid therapy

• The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before the first administration

• Signed and dated written informed consent

• With Liver and kidney function\<1.5×upper limit of normal, such as ALT、AST,BUN,Cre,etc.

• ECOG physical state score ≤ 2 points

• Cardiac function of the New York Society of Cardiac Function ≤ 2

• Patients receiving maintenance treatment (including corticosteroids (less than or equal to 0.5mg/kg prednisone), TPO receptor agonists, etc.) must have a stable dose at least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first administration; The end of rituximab treatment was\>3 months;More than 6 months after splenectomy.

Locations
Other Locations
China
Chinese Academy of Medical Science and Blood Disease Hospital
RECRUITING
Tianjin
Contact Information
Primary
Yunfei Chen, MD
chenyunfei@ihcams.ac.cn
+8618502220788
Time Frame
Start Date: 2023-08-28
Estimated Completion Date: 2026-08
Participants
Target number of participants: 110
Treatments
Experimental: Intervention (Obinutuzumab)
110 enrolled subjects: one infusion
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China

This content was sourced from clinicaltrials.gov