The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11)
Combination Low-dose Rituximab prednisone are effective and safe in the management of
Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).
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Locations near you
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Full eligibility criteria for NCT01317966
Ages eligible for Study
16 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Patients may be male or female, between the ages of 16 ~ 75 years old.
Isolated thrombocytopenia with an otherwise normal peripheral blood smear and no other causes of thrombocytopenia, morphologically normal bone marrow aspirate with normal to increased number of megakaryocytes, and absence of splenomegaly.
To show a platelet count ≤ 30 × 109/L, or platelet count ≥ 30 × 109/L with bleeding manifestations at the moment of the first infusion with the study product.
ＥＣＯＧ performance status ≤ 2.
Patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. Some patients were also refractory to splenectomy.
Patients must be willing and able to give written informed consent.
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 (or coinvestigator).
All locations for NCT01317966
Jinan, Shandong, China, 250012
View full eligibility
Tris trial is registered with FDA with number: NCT01317966. The sponsor of the trial is Ming Hou and it is looking for 0 volunteers for the current phase.
Official trial title: A Multicentre Investigation of Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)
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