drugset / Trial / NCT06288932
Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura.
RandomizedParallel-groupOpen-labelTreatment
Summary
Immune thrombocytopenia Purpura (ITP) is an autoimmune condition delineated by humoral as well as cell mediated immune response against thrombocyte surface proteins GPIIb/IIIa receptors, affecting primary homeostasis leading to mucocutaneous bleeding.ITP is characterized by platelet count \<100 x 109/L. The conventional line of treatment for newly diagnosed ITP is steroids but significant disadvantages have been associated with long term use and a high risk of relapse when reducing the dose. The addition of MMF to the first line treatment of ITP resulted in substantial response and a lower risk of refractory ITP with decreased financial burden and improved outcome.
Timeline
- Start
- 2023-08-18
- Primary completion
- 2024-02-18
- Completion
- 2024-08-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 30 mg/kg | — |
| Subject | Mycophenolate Mofetil | Small molecule | 500 mg | — |
| Subject | Mycophenolate Mofetil | Small molecule | 750 mg | — |
| Subject | Mycophenolate Mofetil | Small molecule | 1 g | — |