drugset / Trial / NCT02834468
DEX Combined With RTX, CSA and IVIG in the Management of Newly Diagnosed ITP Patients
Phase 3
Unknown
100 enrolled
Shandong University
Liaocheng People's Hospital · collabLinyi People's Hospital · collabQingdao University · collab
NaSingle-groupOpen-labelTreatment
Summary
The project was undertaken by Qilu Hospital, Shandong University in China. In order to report the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous immunoglobulin in the management of newly diagnosed ITP patients.
Timeline
- Start
- 2016-06
- Primary completion
- 2018-07
- Completion
- 2018-12
Publications
- Background Medeot M, Zaja F, Vianelli N, Battista M, Baccarani M, Patriarca F, Soldano F, Isola M, De Luca S, Fanin R. Rituximab therapy in adult patients with relapsed or refractory immune thrombocytopenic purpura: long-term follow-up results. Eur J Haematol. 2008 Sep;81(3):165-9. doi: 10.1111/j.1600-0609.2008.01100.x. Epub 2008 May 27.
- Background Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 2.5 mg/kg | Oral |
| Subject | Cyclosporine | Peptide | 3 mg/kg | Oral |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 5 g | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 500 mg | Intravenous |