rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP
- Sponsor
- Shandong University
- Study ID
- NCT01525836
- Phase
- PHASE3
- Status
- Completed
Conditions
- Idiopathic Thrombocytopenic Purpura
- Purpura
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 72 Years
- Healthy Volunteers
- Not accepted
Interventions
- rituximab; recombinant human thrombopoietin (rhTPO) — DRUGpatients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with Rh-TPO( 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 29th day)
- Rituximab — DRUGpatients in recombinant treatment group take Rituximab intravenously at 100 mg weekly for 4 consecutive weeks（Day 1,8,15,22)
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 refractory immune thrombocytopenia (ITP), compared to conventional Rituximab therapy.
Key Dates
- Start date
- May 31, 2011
- Status verified
- May 2013
- Primary completion
- Dec 31, 2013
- Completion
- Jun 30, 2014
Study Design
- Enrollment
- 123 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: combination treatment group120 enrolled patients are randomly picked up to take Rituximab in combination with Rh-TPO at the indicated dose.
- Active Comparator: single treatment group120 enrolled patients are randomly picked up to take Rituximab at the indicated dose.
Primary Outcome Measure
Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 3 months per subject ]