Low-Dose rituximab shows promise for blood disorder
NCT ID NCT01719692
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two low-dose rituximab schedules in 100 adults with immune thrombocytopenia (ITP), a condition causing low platelet counts and bleeding. The goal was to see which regimen better raises platelets and controls bleeding. Participants had failed or relapsed on standard steroid therapy. The trial compared weekly low doses versus a single higher dose.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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100 people
The number who actually took part.
- Started
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Oct 2012
- Finished
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Feb 2016
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-60 years old; * Diagnosis of primary immune thrombocytopenia according to the guidelines of American Society of Hematology for at least 3 months before inclusion; * Platelet count \<30×109/L (measured at least twice during the screening, with at least a 1-week interval); * Failed or dependent on or relapsed after previous treatment with glucocorticoid; * If on glucocorticoid maintenance therapy, dose ≤0.5 mg/kg prednisone or equivalent and stabilised for at least 4 weeks; * Drugs such as azathioprine, danazol, cyclosporine A, tacrolimus, and sirolimus stopped for at least 4 weeks; * Splenectomy more than 6 months previously; * Previous rescue therapy of ITP (including methylprednisolone, platelet transfusion and IVIG) completed at least 2 weeks before the first administration; * Liver and kidney function (including alanine aminotransferase, aspartate aminotransferase, total bilirubin, serum creatine, urea nitrogen, etc.) less than 1.5 times the upper limit of normal value; * Eastern Cooperative Oncology Group performance status ≤2; * Cardiac function classification (New York Heart Association) ≤2; * Understand the research procedure and voluntarily sign a written informed consent form. Exclusion Criteria: * Patients with secondary thrombocytopenia (including myelodysplastic syndrome, aplastic anemia, common variant immunodeficiency disease, hereditary thrombocytopenia, drug-induced thrombocytopenia, pseudothrombocytopenia, connective tissue disease secondary thrombocytopenia, thrombocytopenia after liver disease, etc.); * Previous treatment of RTX or allergic to RTX; * Uncontrollable primary diseases of important organs (including malignant tumor, liver failure, heart failure, kidney failure and other diseases); * HIV-positive status; * Active infection including hepatitis B (HBV), hepatitis C (HCV) and other viral antigens or DNA, RNA positive; cytomegalovirus, Epstein-Barr virus, syphilis chronic or active infection. If HBV core antibodies are positive, HBV-DNA testing is required. * Extensive and severe bleeding, such as hemoptysis, upper gastrointestinal hemorrhage, intracranial hemorrhage, etc. * Heart disease or arrhythmia need treatment, or poorly controlled hypertension; * Thrombotic diseases including pulmonary embolism, thrombosis, atherosclerosis, etc.; * Previously allogeneic stem cell transplantation or organ transplantation; * Mental disorders who are unable to obtain informed consent normally and participate in trials and follow-up; * Symptoms of toxicity from pre-trial treatment have not resolved; * Other severe conditions that may limit participation in the trial (e.g., diabetes; severe cardiac insufficiency; myocardial infarction or unstable arrhythmia or unstable angina within the last 6 months; gastric ulcer; active autoimmune diseases, etc.); * Sepsis or other irregular bleeding; * Taking antiplatelet drugs; * pregnancy, suspected pregnancy (urine human chorionic gonadotropin positive during screening) or lactation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital of Blood disease
Tianjin, Tianjin Municipality, 300020, China
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Other studies related to the condition(s) this trial covers.
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