drugset / Trial / NCT03229746
Reposition of Second Line Treatment in Chronic Immune Thrombocytopenia
RandomizedParallel-groupOpen-labelTreatment
Summary
Hydroxychloroquine has been reported to have a clinically significant effect on the platelet count in systemic lupus thrombocytopenia. Its action may be due to its immune modulator effect. Immune thrombocytopenia (ITP) is known as an immune-mediated acquired disease characterized by transient or persistent decrease of the platelet count. However, refractory ITP is lacking of effective treatments and the efficacy of decitabine in ITP remains poorly understood. Data from this study may provide some idea of Hydroxychloroquine in the treatment of ITP in comparison to other lines of treatment as detected by the standardized definitions.
Timeline
- Start
- 2017-08-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
Publications
- Background Park YH, Yi HG, Lee MH, Kim CS, Lim JH. Clinical efficacy and tolerability of vincristine in splenectomized patients with refractory or relapsed immune thrombocytopenia: a retrospective single-center study. Int J Hematol. 2016 Feb;103(2):180-8. doi: 10.1007/s12185-015-1903-0. Epub 2015 Nov 20.
- Background Poudyal BS, Sapkota B, Shrestha GS, Thapalia S, Gyawali B, Tuladhar S. Safety and Efficacy of Azathioprine as a Second Line Therapy for Primary Immune Thrombocytopenic Purpura. JNMA J Nepal Med Assoc. 2016 Jul-Sep;55(203):16-21.
- Background Cooper N. State of the art - how I manage immune thrombocytopenia. Br J Haematol. 2017 Apr;177(1):39-54. doi: 10.1111/bjh.14515. Epub 2017 Mar 10.
- Background Michel M. Immune thrombocytopenic purpura: epidemiology and implications for patients. Eur J Haematol Suppl. 2009 Mar;(71):3-7. doi: 10.1111/j.1600-0609.2008.01206.x.
- Results Khellaf M, Chabrol A, Mahevas M, Roudot-Thoraval F, Limal N, Languille L, Bierling P, Michel M, Godeau B. Hydroxychloroquine is a good second-line treatment for adults with immune thrombocytopenia and positive antinuclear antibodies. Am J Hematol. 2014 Feb;89(2):194-8. doi: 10.1002/ajh.23609. Epub 2013 Nov 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | 100 mg | — |
| Subject | Hydroxychloroquine | Small molecule | 200 mg | Oral |
| Comparator | Vincristine | Small molecule | 1 mg | Intravenous |