Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01734057|
Recruitment Status : Withdrawn (No eligible patient was enrolled.)
First Posted : November 27, 2012
Last Update Posted : April 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Purpura Idiopathic Thrombocytopenic Purpura||Drug: recombinant human thrombopoietin (rhTPO); rituximab Drug: Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||October 2013|
Experimental: combinant treatment group
120 enrolled patients are randomly picked up to take Rituximab in combination with rhTPO at the indicated dose.
Drug: recombinant human thrombopoietin (rhTPO); rituximab
patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with rhTPO( 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 28th day)
Active Comparator: single treatment group
120 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.
Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.
- Evaluation of platelet response(Chronic ITP) [ Time Frame: up to 1 year per subject ]Chronic ITP is defined as having platelet count less than 100×10^9/L,lasting for more than 12 months.
- Evaluation of platelet response (Complete Response) [ Time Frame: up to 1 year per subject ]CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L without recurrence of thrombocytopenia
- Evaluation of platelet response (R) [ Time Frame: up to 1 year per subject ]R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia
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): NCT01734057
|Qilu Hospital, Shandong University|
|Jinan, Shandong, China|
|Principal Investigator:||Ming Hou, Dr.||Shandong University|