Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 70

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

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment100 (estimated)
SponsorRenata PLC
Industry-sponsored
Locations1 site (Dhaka)
StatusRecruiting
StartedFebruary 7, 2025
Main results expectedAugust 31, 2025
Study endsDecember 31, 2025
Registry record updatedFebruary 18, 2025
Trial IDNCT06531018 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

  • 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.

  • What patients with primary ITP prefer in their treatment

    This survey-based study in the US will ask adults with primary ITP about which treatment options they prefer and why.

    Recruiting Novartis · East Hanover, New Jersey · NCT07786077

  • SG301 SC Injection safety in adults with primary ITP

    This Phase 2 study tests SG301 SC injection at two doses versus placebo in adults with primary immune thrombocytopenia to see if it is safe and helps raise platelet counts.

    Recruiting at 14 sites Phase 2 Hangzhou Sumgen Biotech Co., Ltd. · Fuzhou, Fujian and 21 other locations · NCT07710248

  • Romiplostim plus prednisone vs prednisone alone in adults with newly diagnosed ITP

    This phase 3 trial tests whether adding romiplostim to prednisone helps adults with newly diagnosed primary ITP respond better than prednisone alone.

    Recruiting at 3 sites Phase 3 Amgen · Long Beach, California and 2 other locations · NCT07700238

  • TQB3473 tablets for treating adult primary immune thrombocytopenia

    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.

    Recruiting Phase 3 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Hefei, Anhui and 52 other locations · NCT06900920

  • Long-term observation of children with primary immune thrombocytopenia

    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.

    Recruiting Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT06107582

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.