Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)
- Sponsor
- Ming Hou
- Study ID
- NCT01506414
- Phase
- PHASE3
- Status
- Completed
Conditions
- Idiopathic Thrombocytopenic Purpura
- Purpura
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- rhTPO in combination with Rituximab — DRUGRituximab was given intravenously at a dose of 100 mg weekly for 4 consecutive weeks (Day 1, 8, 15, 22). Rh-TPO (TPIAOTM, a product of Sunshine Pharmaceutical Co Ltd, China, approved by China State Food and Drug Administration) was given subcutaneously at a dose of 1.0 μg/kg（300u/kg）for 14 days (Day 1-14).
Study Details
The purpose of this study is to determine whether Recombinant Human Thrombopoietin (rh-TPO) in combination with Rituximab are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).
Key Dates
- Start date
- Jun 30, 2009
- Status verified
- Jan 2012
- Primary completion
- Aug 31, 2013
- Completion
- Dec 31, 2013
Study Design
- Enrollment
- 91 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: combination treatment
Primary Outcome Measure
Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 3 months per subject ]