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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
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Parvez Ahmed, National Institute of Blood and Marrow Transplant (NIBMT), Pakistan

Brief 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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura (ITP) Drug: Eltrombopag Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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
Drug: Eltrombopag
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




Primary Outcome Measures :
  1. 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 ]
  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Parvez Ahmed, FCPS, MCPS +92-51-9270076 ext 201 parvez101@yahoo.com
Contact: Andleeb Hanif, M.Phil +92-51-9270076 ext 232 andleebhanif123@gmail.com

Locations
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Pakistan
Armed Forces Bone Marrow Transplant Centre Recruiting
Rawalpindi, Punjab, Pakistan, 46000
Contact: Parvez Ahmed, FCPS, MCPS    +92-51-9270076 ext 201    pahmed101@yahoo.com   
Contact: Andleeb Hanif, M.Phil    +92-51-9270076 ext 232    andleebhanif123@gmail.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         
Sponsors and Collaborators
National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
Novartis
Investigators
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Principal Investigator: Parvez Ahmed, FCPS, MCPS Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan
Study Director: Andleeb Hanif, M.Phil andleebhanif123@gmail.com
Publications:
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Responsible Party: Parvez Ahmed, FCPS, MCPS, National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
ClinicalTrials.gov Identifier: NCT02877212    
Other Study ID Numbers: AFBMTC_ITP_2016
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Parvez Ahmed, National Institute of Blood and Marrow Transplant (NIBMT), Pakistan:
ITP
Eltrombopag
Steroid refractory
Fc Receptor
Additional relevant MeSH terms:
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Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases