Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Purpura, Thrombocytopenic, Idiopathic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rhIL-11Combinating Low-dose Rituximab

rhIL-11 (interleukin-11, Juheli) 50 mcg/kg subcutaneously daily for 14 days

Rituximab 100mcg weekly for 4 weeks

rhIL-11

Intervention Type DRUG

Recombinant Human Interleukin-11 (rhIL-11) Combinating Low-dose Rituximab

Interventions

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rhIL-11

Recombinant Human Interleukin-11 (rhIL-11) Combinating Low-dose Rituximab

Intervention Type DRUG

Other Intervention Names

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Rituximab ITP

Eligibility Criteria

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Inclusion Criteria

1. Patients may be male or female, between the ages of 16 \~ 75 years old.
2. 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.
3. 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.
4. ＥＣＯＧ performance status ≤ 2.
5. Patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. Some patients were also refractory to splenectomy.
6. Patients must be willing and able to give written informed consent.

Exclusion Criteria

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
5. 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).
6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
7. 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.
8. Patients who are deemed unsuitable for the study by the investigator (or coinvestigator).

Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No