drugset / Trial / NCT02153060
An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)
Phase 2
Completed
58 enrolled
Shandong University
Anhui Provincial Hospital · collabChinese Academy of Medical Sciences · collabPeking Union Medical College Hospital · collabSecond Hospital of Shanxi Medical University · collabShandong Provincial Hospital · collabShandong University of Traditional Chinese Medicine · collabThe First Affiliated Hospital of Dalian Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The project was undertaking by Qilu Hospital of Shandong University and other 7 well-known hospitals in China. In order to report the efficacy and safety of different dose dexamethasone in treating the immune thrombocytopenia (ITP).
Timeline
- Start
- 2014-05
- Primary completion
- 2015-01
- Completion
- 2015-08
Publications
- 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.
- Background Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.
- Background Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. doi: 10.1056/NEJMoa030254.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 20 mg | — |
| Subject | Dexamethasone | Small molecule | 40 mg | — |