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New treatment option for Immune Thrombocytopenia
Official title A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)
ClinicalTrials.gov ID: NCT06094881
What this study is testing
What is Obinutuzumab Injection [Gazyva]?
Obinutuzumab Injection [Gazyva] is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for immune thrombocytopenia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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...
- Failure or recurrence of previous hormonal therapy or hormone dependence
- The previous emergency treatment of ITP (e.g. methylprednisolone, platelet transfusion, IVIG transfusion) must be completed at least 2 weeks before...
You likely can't join if
- people 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...
- people 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...
- people with extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage;
- people with heart disease that requires treatment or hypertension that has been judged by researchers to be poorly controlled currently;
See the full eligibility criteria
- 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
- 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...
- people 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...
- people 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;
- people with extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage;
- people with heart disease that requires treatment or hypertension that has been judged by researchers to be poorly controlled currently;
- people with any venous or arterial thrombosis, atherosclerosis, and other diseases;
- people with a history of malignant solid tumor or have received allogeneic stem cell transplantation or organ transplantation;
- people with mental disorders who are unable to sign normal informed consent and conduct trials and follow-up;
- people whose toxic symptoms caused by pre-trial treatment have not disappeared;
- people 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...
- people with septicemia or other irregular bleeding;
- Patients taking antiplatelet drugs at the same time;
- Any medical history or condition that the investigator deems unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.