Status:
COMPLETED
rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP
Lead Sponsor:
Shandong University
Collaborating Sponsors:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
The First Affiliated Hospital of Anhui Medical University
Conditions:
Purpura
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
18-72 years
Phase:
PHASE3
Brief Summary
The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining...
Detailed Description
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 refractory ITP adult patients from 14 medical centers in China. One part of the participants are ran...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria for immune thrombocytopenia.
- Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years.
- To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
- Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
- Willing and able to sign written informed consent
Exclusion
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received high-dose steroids or \[2\] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.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 :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT01525836
Start Date
May 1 2011
End Date
June 1 2014
Last Update
April 20 2016
Active Locations (1)
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1
Qilu Hospital, Shandong University
Jinan, Shandong, China