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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 September 2016 |
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Main ID: |
NCT02877212 |
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Date of registration:
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15/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Association of Fc?RIIIA Polymorphism and THPO Expression With Response to Eltrombopag in Refractory ITP Patients
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Scientific title:
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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 |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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75 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02877212 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Parvez Ahmed, FCPS, MCPS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan |
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Name:
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Parvez Ahmed, FCPS, MCPS |
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Address:
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Telephone:
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+92-51-9270076 |
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Email:
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parvez101@yahoo.com |
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Affiliation:
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Name:
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Andleeb Hanif, M.Phil |
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Address:
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Telephone:
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Email:
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Affiliation:
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andleebhanif123@gmail.com |
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Name:
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Parvez Ahmed, FCPS, MCPS |
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Address:
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Telephone:
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+92-51-9270076 |
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Email:
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pahmed101@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Immune Thrombocytopenic Purpura (ITP)
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Intervention(s)
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Drug: Eltrombopag
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Primary Outcome(s)
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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]
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Fc Receptor polymorphism and THPO expression in responders and non-responders
[Time Frame: 6-12 months after inclusion]
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Secondary Outcome(s)
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The Thrombopoietin and cytokine expression among the responders and non responders
[Time Frame: 6 months]
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Secondary ID(s)
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AFBMTC_ITP_2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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