A Phase 3 interventional study of DEX Combined With RTX, CSA and IVIG in Immune Thrombocytopenia, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-07-15.
Sponsored by Shandong University · Phase 3, Interventional, and Treatment
The project was undertaken by Qilu Hospital, Shandong University in China. In order to report the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous immunoglobulin in the management of newly diagnosed ITP patients.
The investigators are undertaking a multicenter trial of 100 primary ITP adult patients from 5 medical centers in China. All participants receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.
697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.
This study's planned enrollment of 100 is above the median of 55 across 472 interventional studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
6.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.
7.Patients who are deemed unsuitable for the study by the investigator.
DEX Combined With RTX, CSA and IVIG All patients are assigned to receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.
Drug: DEX Combined With RTX, CSA and IVIG
The investigators are undertaking a multicenter trial of 100 primary ITP adult patients from 5 medical centers in China. All participants receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.
Also known as: The combined therapy for ITP
Evaluation of platelet response (Complete Response)
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10\^9/L
Time frame: The time frame is up to 3 months per subject
Evaluation of platelet response (Response)
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia.
Time frame: The time frame is up to 3 months per subject
Evaluation of platelet response (No Response)
NR.No response (NR) was defined as platelet count \< 30 × 10\^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
Time frame: The time frame is up to 3 months per subject
Evaluation of platelet response (relapses)
A relapses was defined as platelet count falls below 30×10\^9/L or bleeding accrues after achieving R or CR.
Time frame: The time frame is up to 9 months per subject
The number and frequency of therapy associated adverse events
Time frame: up to 9 months per subject
Plan to share: No
This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Shandong University