NCT05995054 A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Immune Thrombocytopenia
| NCT ID | NCT05995054 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-08-28 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 110 participants in total. It began in 2023-08-28 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Subjects with extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage; * Subjects with heart disease that requires treatment or hypertension that has been judged by researchers to be poorly controlled currently; * Subjects with any venous or arterial thrombosis, atherosclerosis, and other diseases; * Subjects with a history of malignant solid tumor or have received allogeneic stem cell transplantation or organ transplantation; * Subjects with mental disorders who are unable to sign normal informed consent and conduct trials and follow-up; * Subjects whose toxic symptoms caused by pre-trial treatment have not disappeared; * Subjects with other serious diseases that may limit their participation in this trial (diabetes; severe cardiac insufficiency; myocardial obstruction or unstable arrhythmia or unstable angina pectoris in the last 6 months; gastric ulcer; active autoimmune disease, etc.); * Subjects with septicemia or other irregular bleeding; * Female subjects who are nursing or pregnant/suspected pregnant (positive pregnancy tests for human chorionic gonadotropin in urine during screening). * Patients taking antiplatelet drugs at the same time;
Contact & Investigator
Lei Zhang, MD
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Science and Blood Disease Hospital
Frequently Asked Questions
Who can join the NCT05995054 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05995054 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05995054 currently recruiting?
Yes, NCT05995054 is actively recruiting participants. Contact the research team at chenyunfei@ihcams.ac.cn for enrollment information.
Where is the NCT05995054 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05995054 clinical trial?
NCT05995054 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Lei Zhang, MD at Chinese Academy of Medical Science and Blood Disease Hospital. The trial plans to enroll 110 participants.