Status:
COMPLETED
The Study of Different Dose Rituximab in the Treatment of ITP
Lead Sponsor:
Shandong University
Conditions:
Purpura, Thrombocytopenic, Idiopathic
Immune Thrombocytopenia
Eligibility:
All Genders
10-70 years
Phase:
PHASE4
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 t...
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 1...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03258866
Start Date
January 1 2010
End Date
December 31 2016
Last Update
August 23 2017
Active Locations (1)
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1
Qilu hospital, Shandong University
Jinan, Shandong, China, 250012