The Study of Different Dose Rituximab in the Treatment of ITP

Last updated: August 22, 2017
Sponsor: Shandong University
Overall Status: Completed

Phase

4

Condition

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Thrombocytopenia And Thrombocytopenia Prevention

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT03258866
RTX 4v1 in ITP
  • Ages 10-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 islarge, 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

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 oruncontrolled disease or condition related to or impacting cardiac function (e.g.,unstable angina, congestive heart failure, uncontrolled hypertension or cardiacarrhythmia)

  3. Female patients who are nursing or pregnant, who may be pregnant, or who contemplatepregnancy during the study period.

  4. Have a known diagnosis of other autoimmune diseases, established in the medicalhistory and laboratory findings with positive results for the determination ofantinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or directCoombs test.

  5. Patients who are deemed unsuitable for the study by the investigator.

Study Design

Total Participants: 62
Study Start date:
January 01, 2010
Estimated Completion Date:
December 31, 2016

Study 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.

Connect with a study center

  • Qilu hospital, Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

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