Association of FcγRIIIA Polymorphism and THPO Expression With Response to Eltrombopag in Refractory ITP Patients
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|ClinicalTrials.gov Identifier: NCT02877212|
Recruitment Status : Unknown
Verified August 2016 by Parvez Ahmed, National Institute of Blood and Marrow Transplant (NIBMT), Pakistan.
Recruitment status was: Recruiting
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenic Purpura (ITP)||Drug: Eltrombopag||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Association of FC Gamma RIIIA Polymorphism and Thrombopoietin (THPO) Expression With Response to TPO Agonists in Refractory ITP and the Impact of Therapy on B and T Cells Subsets in the Patients With Mutated Genotypes|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||September 2017|
Experimental: Study subjects
Steroid refractory ITP patients will be given Eltrombopag to investigate the association of treatment outcome with Fc Receptor polymorphism and THPO expression in responders and non responders following comparison correlation with ITP patients treated with standard IST as control group
Eltrombopag will be given to steroid refractory ITP patients and ITP patients treated with standard Immunosuppressive therapy (IST) will be taken as control.
Other Name: TPO Receptor agonists
- The overall response rate 4-6 months after treatment defined by a platelet count > 30 x 109/L with at least a two-fold increase from the initial (pre-treatment) count [ Time Frame: 6 months after inclusion ]
- Fc Receptor polymorphism and THPO expression in responders and non-responders [ Time Frame: 6-12 months after inclusion ]The inclusion of 75 patients (25 ITP patients treated with Eltrombopag and 50 subjects with ITP treated with other standard IST) would be considered as sufficient to show an association of the FcgammaRIIIA V158F genotypes distribution and THPO expression with the response for the patients treated with Eltrombopag and other IST at different time points; (M0, M3 and M6 )** **M0=pretreatment sample at 0 month; M3=sample after 3 months of treatment; M6= sample after 6 months of treatment.
- The Thrombopoietin and cytokine expression among the responders and non responders [ Time Frame: 6 months ]The Thrombopoietin and cytokine expression among the responders and non responders will be taken as secondary outcome to evaluate the influence of Fc gamma RIIIA mutated genotypes to evaluate the correlation between steroid refractory and control groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877212
|Contact: Parvez Ahmed, FCPS, MCPS||+92-51-9270076 ext firstname.lastname@example.org|
|Contact: Andleeb Hanif, M.Phil||+92-51-9270076 ext email@example.com|
|Armed Forces Bone Marrow Transplant Centre||Recruiting|
|Rawalpindi, Punjab, Pakistan, 46000|
|Contact: Parvez Ahmed, FCPS, MCPS +92-51-9270076 ext 201 firstname.lastname@example.org|
|Contact: Andleeb Hanif, M.Phil +92-51-9270076 ext 232 email@example.com|
|Principal Investigator: Parvez Ahmed, FCPS, MCPS|
|Sub-Investigator: Andleeb Hanif, M.Phil|
|Sub-Investigator: Tariq M Satti, FCPS|
|Sub-Investigator: Qamar Un Nisa Ch, FCPS|
|Sub-Investigator: Kamran Mehmood, FCPS|
|Principal Investigator:||Parvez Ahmed, FCPS, MCPS||Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan|
|Study Director:||Andleeb Hanif, M.Philfirstname.lastname@example.org|