rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP
|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|
|Primary Completion Date :||December 2013|
|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 ]
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|