Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thr
This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line therapy
| Condition(s) | Primary Immune Thrombocytopenia (ITP) |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line therapy and /or splenectomy. |
| Who can participate | Inclusion Criteria: 1. Signed written informed consent 2. Age from 18 to 60 years old 3. Diagnosed with ITP and have a platelet count of \<30 ×10\^9/L on Day 1 (or within 48 hours prior to dosing on Day 1). 4. Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy. 5. Subjects treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completed prior to randomization, or must not be increasing a dose after enrollment. 6. No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thro |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Lead sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Locations | Tianjin, China |
| Start date | 2020-08-10 |
| NCT ID | NCT04518475 |
| Official listing | https://clinicaltrials.gov/study/NCT04518475 |