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

Launched by RENATA PLC · Jul 28, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called eltrombopag as a first-line treatment for patients who have recently been diagnosed with Primary Immune Thrombocytopenia (ITP), a condition where the body doesn’t produce enough platelets, leading to a risk of bleeding. The trial will involve 100 participants, aged 18 to 70, with a platelet count of 30 or lower. If someone is interested in joining, they will go through a thorough health check and will need to give their consent before being randomly assigned to receive either eltrombopag with a steroid (prednisolone) or eltrombopag with a placebo (a non-active treatment).

Participants will be closely monitored over a year, with regular check-ups to assess their health and platelet levels, as well as any bleeding issues. The study is designed to be fair and unbiased, so neither the participants nor the researchers will know who is receiving the active treatment or the placebo. This helps ensure that the results are reliable. The findings from this trial could provide important information about how effective eltrombopag is for treating newly diagnosed ITP and may help improve future treatment options for patients.

Gender

ALL

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.