Using Eltrombopag as a first treatment for Primary Immune Thrombocytopenia

Efficacy of Eltrombopag & Prednisolone Versus Prednisolone Monotherapy in Newly Diagnosed Immune Thrombocytopenia- A Randomized Control Trial

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
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Renata PLC (Industry-sponsored)
• Locations: 1 site (Dhaka)
• Trial ID: NCT06531018 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients with chronic or persistent ITP, secondary ITP, or those with significant bleeding at presentation may not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Dhaka

• 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

Conditions Primary Immune Thrombocytopenia; Primary ITP; Eltrombopag; First-line Therapy