rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP
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|ClinicalTrials.gov Identifier: NCT01525836|
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Purpura Idiopathic Thrombocytopenic Purpura||Drug: rituximab; recombinant human thrombopoietin (rhTPO) Drug: Rituximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||June 2014|
Experimental: combination treatment group
120 enrolled patients are randomly picked up to take Rituximab in combination with Rh-TPO at the indicated dose.
Drug: rituximab; recombinant human thrombopoietin (rhTPO)
patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with Rh-TPO( subcutaneously , 300U/kg for 14 consecutive days,followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 29th day)
Active Comparator: single treatment group
120 enrolled patients are randomly picked up to take Rituximab at the indicated dose.
patients in recombinant treatment group take Rituximab intravenously at 100 mg weekly for 4 consecutive weeks（Day 1,8,15,22)
- Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 3 months per subject ]CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L
- Evaluation of platelet response (Response) [ Time Frame: The time frame is up to 3 months per subject ]R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.
- Evaluation of platelet response (No Response) [ Time Frame: The time frame is up to 3 months per subject ]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.
- Evaluation of platelet response (relapses) [ Time Frame: The time frame is up to 3 months per subject ]A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
- The number and frequency of therapy associated adverse events [ Time Frame: up to 3 months per subject ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525836
|Qilu Hospital, Shandong University|
|Jinan, Shandong, China|
|Principal Investigator:||Minf Hou, Dr.||Shandong University|