NCT06288932

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

An Outcome Study of Conventional Steroids Vs. Steroids Combined with Mycophenolate for the Management of Newly Diagnosed Immune Thrombocytopenia Purpura: a Cost Effective Measure in Developing Nations.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: National Institute of Blood and Marrow Transplant (NIBMT), Pakistan · Other Government
• Sex: All
• Age: 5 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Immune Thrombocytopenia Purpura (ITP) is an acquired, immune-mediated disorder characterized by a severe decrease in peripheral thrombocyte count to less than 100 x 10⁹/L, leading to mucocutaneous bleeding. Our primary objective is to evaluate the efficacy of adding Mycophenolate Mofetil (MMF) alongside steroids in the first-line treatment of ITP, aiming for an enhanced therapeutic response, lower risk of refractory and chronic ITP, reduced financial burden, and improved overall outcomes. The study aims to validate the efficacy and safety of MMF as a first-line treatment option for ITP while reducing the economic burden and risk of relapse associated with the condition

Conditions

• Immune Thrombocytopenia Purpura

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil (MMF) Treatment	The first-line treatment of immune thrombocytopenia purpura with Mycophenolate Mofetil produced a significant response, a lowered likelihood of refractory ITP, a better outcome, and less financial burden.

Timeline

• Start date: 2023-08-18
• Primary completion: 2024-02-18
• Completion: 2024-08-18
• First posted: 2024-03-01
• Last updated: 2024-11-06

Locations

1 site across 1 country: Pakistan