rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP
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|ClinicalTrials.gov Identifier: NCT01734044|
Recruitment Status : Completed
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); dexamethasone Drug: Dexamethasone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||November 2014|
Experimental: combination treatment group
100 enrolled patients are randomly picked up to take rhTPO in combination with dexamethasone at the indicated dose.
Drug: recombinant human thrombopoietin (rhTPO); dexamethasone
Patients in recombination treatment group take 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), in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days)
Active Comparator: single treatment group
100 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 [ 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 (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): NCT01734044
|Qilu Hospital, Shandong University|
|Jinan, Shandong, China|
|Principal Investigator:||Ming Hou, Dr.||Shandong University|