rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP
|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
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|