Association of FcγRIIIA Polymorphism and THPO Expression With Response to Eltrombopag in Refractory ITP Patients

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Idiopathic thrombocytopenic purpura (ITP) is an autoimmune disease characterized by antibody-mediated platelet destruction. The complex pathogenesis of ITP with multiple challenges to immune system in terms of genetic predisposition, infection, responsiveness to immunosuppressive therapy (IST) and inhibition of platelet production has proven the diversity of constraints in diagnosing and treating ITP. Thrombopoietin receptor agonist (Eltrombopag) is specifically indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. This clinical trial aims to investigate the association of Fc gammaRIIIA gene (V158F) genetic predisposition with treatment outcome of Immune Thrombocytopenia (ITP) in refractory ITP patients and especially with Eltrombopag.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Armed Forces Bone Marrow Transplant Center, Rawalpindi, Pakistan; National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
• Collaborator: Novartis

Criteria

Inclusion Criteria:

• Steroid refractory ITP defined according to the recent consensual criteria (Rodeghiero F et al. Blood 2009),

• Informed consent. The control patients will be included as under;

• Age and sex matched controls

• Control ITP group (treated with standard immunosuppressive therapy (IST) as first and second line treatment)

Exclusion Criteria:

• Secondary ITP

• Other hematological and malignant disorders