A Phase 3 interventional study of recombinant human thrombopoietin (rhTPO); dexamethasone and Dexamethasone in Purpura and Idiopathic Thrombocytopenic Purpura, sponsored by Shandong University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by Shandong University · Phase 3, Interventional, and Treatment
The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 200 primary ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300Units/kg for7-14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with dexamethasone (given intravenously at a dose of 40 mg per day for 4days, the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). Platelet count was evaluated before and after treatment, in order to report the conversion ratio of primary ITP to chronic ITP.
263 studies on the registry are indexed under Purpura; 27 are open to participants now.
This study's enrollment of 158 is above the median of 50 across 171 interventional studies indexed under Purpura.
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100 enrolled patients are randomly picked up to take rhTPO in combination with dexamethasone at the indicated dose.
Drug: recombinant human thrombopoietin (rhTPO); dexamethasone
100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.
Drug: 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)
Also known as: Recombinant Human Thrombopoietin, Recombinant Human TPO, rhTPO combine with Dexamethasone, Recombinant Human Thrombopoietin combine with Dexamethasone, Recombinant Human TPO combine with Dexamethasone
Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.
Evaluation of platelet response
Chronic ITP is defined as having platelet count less than 100×10\^9/L,lasting for more than 12 months.
Time frame: up to 1 year per subject
Evaluation of platelet response (R)
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia
Time frame: up to 1 year per subject
This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.
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Shandong University