Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
- Sponsor
- Shandong University
- Study ID
- NCT01734057
- Phase
- PHASE3
- Status
- Withdrawn
Conditions
- Idiopathic Thrombocytopenic Purpura
- Purpura
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- recombinant human thrombopoietin (rhTPO); rituximab — DRUGpatients 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)
- Dexamethasone — DRUGPatients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.
Study Details
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 Rituximab for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.
Key Dates
- Start date
- Jul 31, 2012
- Status verified
- Nov 2012
- Primary completion
- Jul 31, 2013
- Completion
- Oct 31, 2013
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: combinant treatment group120 enrolled patients are randomly picked up to take Rituximab in combination with rhTPO at the indicated dose.
- Active Comparator: single treatment group120 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.
Primary Outcome Measure
Evaluation of platelet response(Chronic ITP) [ Time Frame: up to 1 year per subject ]