The Study of Different Dose Rituximab in the Treatment of ITP
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ClinicalTrials.gov Identifier: NCT03258866 |
Recruitment Status :
Completed
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
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Condition or disease | Intervention/treatment | Phase |
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Purpura, Thrombocytopenic, Idiopathic Immune Thrombocytopenia | Drug: Rituximab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia |
Actual Study Start Date : | January 1, 2010 |
Actual Primary Completion Date : | December 31, 2015 |
Actual Study Completion Date : | December 31, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: group A
In group A, Rituximab was given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22).
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Drug: Rituximab
given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)
Other Name: Mabthera |
Experimental: group B
In group B, Rituximab was given with a single dose of 375mg/m2
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Drug: Rituximab
given with a single dose of 375mg/m2
Other Name: Mabthera |
- Evaluation of platelet response(continuous response rate) [ Time Frame: up to 1 year per subject ]Complete Response:a sustained (≥ 3 months) platelet count≥100×10^9/L;response: a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia;No response (NR): platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
- therapy associated adverse events [ Time Frame: up to 1 year per subject ]The number and frequency of therapy associated adverse events

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Ages Eligible for Study: | 10 Years to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meet the diagnostic criteria for immune thrombocytopenia.
- Male or female, between the ages of 10 ~ 70 years.
- Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is large, without immunosuppressive therapy or immunosuppressive treatment ineffective
- To show a platelet count < 30×10^9/L, or with bleeding manifestations.
- Eastern Cooperative Oncology Group(ECOG)performance status ≤ 2
Exclusion Criteria:
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- Patients who are deemed unsuitable for the study by the investigator.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258866
China, Shandong | |
Qilu hospital, Shandong University | |
Jinan, Shandong, China, 250012 |
Principal Investigator: | Ming Hou, Dr | Shandong University |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Ming Hou, Professor and Director, Shandong University |
ClinicalTrials.gov Identifier: | NCT03258866 |
Other Study ID Numbers: |
RTX 4v1 in ITP |
First Posted: | August 23, 2017 Key Record Dates |
Last Update Posted: | August 23, 2017 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
thrombocytopenia Immune Thrombocytopenia purpura |
Thrombocytopenia Purpura Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Platelet Disorders Hematologic Diseases Blood Coagulation Disorders Hemorrhage Pathologic Processes Skin Manifestations |
Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |