Using Eltrombopag as a first treatment for Primary Immune Thrombocytopenia
Official title: Efficacy of Eltrombopag & Prednisolone Versus Prednisolone Monotherapy in Newly Diagnosed Immune Thrombocytopenia- A Randomized Control Trial
Run by Renata PLC · NCT06531018 · Data updated 2026-11-12
This study is testing if a new medication called eltrombopag can help people who are newly diagnosed with Primary Immune Thrombocytopenia by increasing their platelet counts and reducing bleeding.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Renata PLC Industry-sponsored |
| Locations | 1 site (Dhaka) |
| Status | Recruiting |
| Started | February 7, 2025 |
| Main results expected | August 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT06531018 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 70 years with newly diagnosed ITP and a platelet count of 30x10^9/L or lower.
✕Probably not a fit
Patients with chronic or persistent ITP, secondary ITP, or those with significant bleeding at presentation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a double-blind, placebo-controlled, randomized study aimed at evaluating the effectiveness of eltrombopag as a first-line therapy for patients newly diagnosed with Primary Immune Thrombocytopenia (ITP). The trial will enroll 100 participants who meet specific inclusion criteria and will be randomly assigned to receive either eltrombopag combined with prednisolone or a placebo. Participants will undergo thorough clinical evaluations and laboratory tests to monitor platelet counts and instances of spontaneous bleeding throughout the study duration. The trial is conducted at the Department of Hematology, Dhaka Medical College Hospital, over the course of one year.
Why it matters
Potential benefit: If successful, this study could provide a new effective first-line treatment option for patients with Primary Immune Thrombocytopenia.
How similar studies have gone: Previous studies have shown promise in using eltrombopag for ITP, but this specific approach as a first-line therapy is being evaluated for the first time.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Dhaka Medical College Hospital
Dhaka, Bangladesh Recruiting
Study contacts
- Principal investigator: Md Manirul Islam, MBBS,FCPS — Dhaka Medical College
- Study coordinator: Md Manirul Islam, MBBS,FCPS
- Email: manirk54@yahoo.com
- Phone: +8801715049573
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This study is testing if TQB3473 tablets can help adults with chronic immune thrombocytopenia who haven't responded well to standard treatments feel better and have more stable blood platelet levels.
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This study looks at how children with primary immune thrombocytopenia are treated and what their long-term health outcomes are in order to better understand the condition.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.