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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-18
SponsorInstitute of Hematology & Blood Diseases Hospital, China

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]

Treatment groups

60 Participants
are divided into 1 treatment group