drugset / Trial / NCT06288932

Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycopehnolate in Newly Diagnosed Immune Thrombocytopenia Purpura.

NCT06288932

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

EvaluationDrugModalityDoseRoute
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