The Study of Different Dose Rituximab in the Treatment of ITP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-01

Study Completion Date

2016-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Purpura, Thrombocytopenic, Idiopathic Immune Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)

group B

In group B, Rituximab was given with a single dose of 375mg/m2

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

given with a single dose of 375mg/m2

Interventions

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Rituximab

given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)

Intervention Type DRUG

Rituximab

given with a single dose of 375mg/m2

Intervention Type DRUG

Other Intervention Names

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Mabthera Mabthera

Eligibility Criteria

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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

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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No