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

NCT06531018 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-02-18

No results posted yet for this study

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.

Conditions

  • Primary Immune Thrombocytopenia

Interventions

DRUG

Eltrombopag 25 MG

Eltrombopag 25 mg daily and Prednisolone 1-2mg/kg, selected by block randomization from Day1 to Day 28. Both investigators and patients will be blinded.

DRUG

Prednisolone

Prednisolone 1-2 mg/kg and Placebo(same as eltrombopag 25mg Tablet), selected by block randomization from Day1 to Day 28. Both investigators and patients will be blinded.

Sponsors & Collaborators

  • Renata PLC

    lead INDUSTRY

Principal Investigators

  • Md Manirul Islam, MBBS,FCPS · Dhaka Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-07
Primary Completion
2025-08-31
Completion
2025-12-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531018 on ClinicalTrials.gov