Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia.
NCT Number: NCT06531018
Acronym: EIT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Primary Immune Thrombocytopenia
Interventions: DRUG: Eltrombopag 25 MG|DRUG: Prednisolone
Sponsor: Manirul Islam
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-08-30
Locations: Dhaka Medical College Hospital, Dhaka, 1000, Bangladesh

Summary:
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.

Primary Outcome Measures: Changes in Platelet count, Compare change in platelet count in two groups, 28 days (platelet count will be measured at the end of 1st, 2nd and 4th week)|Spontaneous bleeding, Compare number of Spontaneous bleeding in two groups, 28 days (Spontaneous bleeding episodes will be noted by face to face interview at the end of 1st, 2nd and 4th week)
Secondary Outcome Measures: Changes in hemoglobin, Compare change in hemoglobin count in two groups, 28 days (hemoglobin will be measured at the end of 1st, 2nd and 4th week)|Changes in Total WBC count, Compare change in total WBC count in two groups, 28days (WBC count will be measured at the end of 1st, 2nd and 4th week)|Change in ALT, Compare change in ALT in two groups, 28 days ( ALT will be measured at the end of 1st, 2nd and 4th week)|Change in AST, Compare change in AST, 28 days ( AST will be measured at the end of 1st, 2nd and 4th week)|Change in S.Createnine, Compare change in S.Createnine in two groups, 28 days (S.Createnine will be measured at the end of 1st, 2nd and 4th week)|Change in RBS, Compare change RBS in two groups, 28 days (RBS will be measured at the end of 1st, 2nd and 4th week)