Status:
UNKNOWN
Rituximab Combining Bortezomib Versus Rituximab in Management of ITP
Lead Sponsor:
Shandong University
Collaborating Sponsors:
The Affiliated Hospital of Qingdao University
Yantai Yuhuangding Hospital
Conditions:
Immune Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The project was undertaking by Qilu Hospital of Shandong University and other 2 well-known hospitals in China. In order to report the efficacy and safety of rituximab combining with bortezomib for the...
Detailed Description
The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 100 ITP adult patients from 3 medical centers in China. One part of the participants are rando...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria for immune thrombocytopenia.
- Not previously used rituximab and bortezomid,untreated 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.
Exclusion
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- 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 :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03443570
Start Date
March 1 2018
End Date
March 1 2021
Last Update
February 23 2018
Active Locations (1)
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1
Qilu hospital, Shandong University
Jinan, Shandong, China, 250012