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Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia.

RecruitingPhase 1, Phase 2Ages 18 Years - 70 YearsAllRenata PLC
NCT06531018 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This will be a double-blind, placebo-control, randomized clinical trial conducted in the Department of Hematology, DMCH for one year. This study will help to establish the role of eltrombopag as a first-line therapy in newly diagnosed ITP. Newly diagnosed ITP patients will be selected after meeting inclusion and exclusion criteria, they will be thoroughly informed about the study, used drugs, randomization, risks, benefits, and follow-up. If they agree to participate, their consent will be taken and they will be enrolled in the study. A detailed history and clinical exam will be done. Primary investigation will be - CBC PBF, RBS, ANA, TSH, Anti H. pyloriIgG, Anti-HCV, APTT, and BMS (if indicated). The main outcome variable will be platelet count and number of spontaneous bleeding. Total sample size would be 100 (50 in each group). Enrolled patients would be divided into two groups (1:1)

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients with newly diagnosed ITP 2. Platelet Count ≤ 30x109/L 3. Age between 18 to 70 years. Exclusion Criteria: 1. Persistent or chronic ITP 2. Pregnant women 3. Secondary ITP- ITP due to SLE, Anti-phospholipid syndrome, Evans syndrome, HCV or H Pylori associated ITP. 4. History of vaccination, recent viral infection, fever 5. Evan's Syndrome 6. Known case of chronic renal failure or liver diseases 7. Grade 3 or 4 bleeding at presentation.
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What it tests

  • Eltrombopag 25 MG
  • Prednisolone
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Where

1 site
Dhaka Medical College Hospital
Dhaka, Bangladesh
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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