Status:
COMPLETED
Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)
Lead Sponsor:
Ming Hou
Collaborating Sponsors:
Peking Union Medical College Hospital
Chinese Academy of Medical Sciences
Conditions:
Purpura
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether Recombinant Human Thrombopoietin (rh-TPO) in combination with Rituximab are effective and safe in the management of Steroid-Resistant/Relapsed Immune ...
Detailed Description
Rituximab was given intravenously at a dose of 100 mg weekly for 4 consecutive weeks (Day 1, 8, 15, 22). Rh-TPO (TPIAOTM, a product of Sunshine Pharmaceutical Co Ltd, China, approved by China State Fo...
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.
- 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 second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- Received high-dose steroids or 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 chronic 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 :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01506414
Start Date
June 1 2009
End Date
December 1 2013
Last Update
April 20 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012