About this trial
To evaluate the safety and efficacy of Obinutuzumab in the treatment of pediatric primary immune thrombocytopenia in patients who have not responded adequately or relapsed after first-line glucocorticoid treatment.
Eligibility criteria
Qualifiers
Age 12-18 years old, male or female
Conform to the diagnostic criteria of persistent or chronic immune Thrombocytopenia (ITP)
With a platelet count of <30 X 10^9/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 10^9/L)
Failure or recurrence of previous hormonal therapy or hormone dependence
Disqualifiers
Subjects with primary disease of important organs (liver, kidney, heart, etc.), or with immune system diseases;
Secondary thrombocytopenia caused by various reasons, such as connective tissue disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency, lymphoma, etc.;
Subjects infected with human immunodeficiency virus (HIV);
Uncontrollable or active infections during the screening period, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, or positive syphilis antigen;
Trial design
Treatments tested in this trial
- Obinutuzumab Injection [Gazyva]