NCT06531018 Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia.
| NCT ID | NCT06531018 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Renata PLC |
| Condition | Primary Immune Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-02-07 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Md Manirul Islam, MBBS,FCPS
PRINCIPAL INVESTIGATOR
Dhaka Medical College
Frequently Asked Questions
Who can join the NCT06531018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Primary Immune Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06531018 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06531018 currently recruiting?
Yes, NCT06531018 is actively recruiting participants. Contact the research team at manirk54@yahoo.com for enrollment information.
Where is the NCT06531018 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh.
Who is sponsoring the NCT06531018 clinical trial?
NCT06531018 is sponsored by Renata PLC. The principal investigator is Md Manirul Islam, MBBS,FCPS at Dhaka Medical College. The trial plans to enroll 100 participants.