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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Primary Immune Thrombocytopenia

In brief

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) by block randomization. One group will get Eltrombopag\& Prednisolone and other group will get Eltrombopag\& Placebo. Researchers or any one related to the study in DMCH, patients \& their attendants, no one will know which patient will get placebo or eltrombopag. Only a respectable third party will know the information. A patient would be followed up on 1st, 2nd and 4th week of starting therapy. Patients would be evaluated in every follow up by history, physical examination and investigation. History of any spontaneous bleeding event, any discomfort or new symptoms science last follow up will be noted. General examination will be performed in every follow-up. CBC, RBS, ALT, AST, creatinine will be done in every follow-up. Data will be collected on a pre-designed case record form and will be collected through face-to-face interviews, physical examination, and laboratory reports. After data collection data will be edited, cleaned, and prepared for analysis at the end of the study. The statistical analysis will be conducted using SPSS version 25 statistical software. The results of the study will be published in national and international journals.

Key facts

Study ID

NCT06531018

Run by

Renata PLC

People needed

100

Starts

2025-02-07

Expected to finish

2025-12-31

Last updated by the study team

2025-02-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with newly diagnosed ITP
• Platelet Count ≤ 30x109/L
• Age between 18 to 70 years.

You may not qualify if…

• Persistent or chronic ITP
• Pregnant women
• Secondary ITP- ITP due to SLE, Anti-phospholipid syndrome, Evans syndrome, HCV or H Pylori associated ITP.
• History of vaccination, recent viral infection, fever
• Evan's Syndrome
• Known case of chronic renal failure or liver diseases
• Grade 3 or 4 bleeding at presentation.

Where it is running

• Dhaka Medical College Hospital — Dhaka, Bangladesh (enrolling)

Full record on ClinicalTrials.gov

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