The Study of Different Dose Rituximab in the Treatment of ITP

Phase 4

Completed

• Conditions: Immune Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
• Interventions: Drug: Rituximab

• Registration Number: NCT03258866
• Lead Sponsor: Shandong University

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University in China. In order to compare the efficacy, safety and response duration of different dose of rituximab in patients primary immune thrombocytopenia(pITP).

Detailed Description

62 patients with pITP who had failed to respond to glucocorticosteroids were randomly divided into 2 groups: group A(n = 32) and group B(n = 30). 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). In group B, Rituximab was given with a single dose of 375mg/m2. The clinical effect, onset time, duration of efficacy and adverse reactions were observed to compare the efficacy and safety of two different plans.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-08
• Study First Submitted: 2017-08-18
• Study First Submitted QC: 2017-08-22
• Last Update Submitted: 2017-08-22
• Study First Posted: 2017-08-23
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Male or female, between the ages of 10 ~ 70 years.
3. Normal glucocorticoid therapy is ineffective or effective but the maintenance dose is large, without immunosuppressive therapy or immunosuppressive treatment ineffective
4. To show a platelet count < 30×10^9/L, or with bleeding manifestations.
5. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2

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Exclusion Criteria

1. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
2. 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)
3. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
4. 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.
5. Patients who are deemed unsuitable for the study by the investigator.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	Rituximab	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).
group B	Rituximab	In group B, Rituximab was given with a single dose of 375mg/m2

Primary Outcome Measures

Name	Time	Method
Evaluation of platelet response(continuous response rate)	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.

Secondary Outcome Measures

Name	Time	Method
therapy associated adverse events	up to 1 year per subject	The number and frequency of therapy associated adverse events

Trial Locations

Locations (1)

Qilu hospital, Shandong University; 🇨🇳 Jinan, Shandong, China