Actively Recruiting
A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24
60
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 18 years, any gender
- Diagnosed with persistent or chronic immune thrombocytopenia (ITP)
- Platelet count below 30 x 10⁹/L confirmed within 2 days before treatment, with at least two tests one week apart during screening
- Failed or relapsed after previous hormonal therapy or hormone dependence
- Completed any emergency ITP treatment at least 2 weeks before first Obinutuzumab dose
- Signed informed consent
- Liver and kidney function tests less than 1.5 times the upper normal limit
- Eastern Cooperative Oncology Group (ECOG) physical state score of 2 or less
- New York Heart Association cardiac function class 2 or less
- Stable doses of maintenance treatments (corticosteroids ≤0.5 mg/kg prednisone, TPO receptor agonists) for at least 4 weeks before treatment
- Stopped azathioprine, danazol, cyclosporin A, tacrolimus, sirolimus at least 4 weeks before treatment
- Completed rituximab treatment more than 3 months ago
- More than 6 months since splenectomy
You will not qualify if you...
- Presence of primary diseases affecting important organs (liver, kidney, heart) or immune system diseases
- Secondary thrombocytopenia from causes like connective tissue disorders, bone marrow failure, malignancy, drugs, inherited thrombocytopenia, immune deficiencies, lymphoma
- Infection with HIV
- Uncontrolled or active infections including hepatitis B, hepatitis C, cytomegalovirus, Epstein-Barr virus, or positive syphilis antigen
- Severe or extensive bleeding such as hemoptysis, upper gastrointestinal hemorrhage, or intracranial hemorrhage
- Heart disease requiring treatment or poorly controlled hypertension
- Any venous or arterial thrombosis, atherosclerosis, or related diseases
- History of malignant solid tumor, or previous stem cell or organ transplantation
- Mental disorders preventing informed consent or study participation
- Ongoing toxic symptoms from prior treatments
- Serious diseases limiting trial participation, including diabetes, severe heart failure, myocardial obstruction, unstable arrhythmia, unstable angina, gastric ulcer, active autoimmune disease
- Septicemia or other abnormal bleeding
- Current use of antiplatelet drugs
- Any other medical condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Tianjin, China
Actively Recruiting
Research Team
T
Ting Sun, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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