CompletedPhase 4

Efficacy of Combination of Hdroxyurea and Thalidomide Over Hydroxyurea or Thalidomide in the Treatment of Transfusion Dependent Thalassemia in Children

Bangladesh90 participantsStarted 2023-11-01

Plain-language summary

The goal of this clinical trial is to find out the efficacy of combined Hydroxyurea and thalidomide transfusion dependent thalassemia patients. The main objectives are to compare the level of Hb, Transfusion interval, serum ferritin level before \& after treatment between single and combination of thalidomide and HU. Researcher will compare the effectiveness of combined hydroxyurea and thalidomide and hydroxyurea and thalidomide alone. Participants will be divided in three groups: Group I: will take combination of HU and Thalidomide. Group II: Will take HU alone and Group III: Will take Thalidomide alone and outcome will be recorded.

Who can participate

Age range

3 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients diagnosed as transfusion dependent thalassemia * Age ranged from 3-18 years * Blood transfusion more than 1 year. * no bleeding disorder Exclusion Criteria: * Active systemic co-morbidity, * Past personal or family history of thrombophilia, * Recent fracture or recent major surgery * Use of drugs that might affect Hb levels 15 days before enrollment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Hb Level

Timeframe: 12 weeks after treatment initiation

Change in Blood transfusion frequency

Timeframe: 12 weeks after treatment initiation

Change in HbF

Timeframe: 12 weeks after treatment initiation

Trial details

NCT IDNCT06299670

SponsorBangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-30

View on ClinicalTrials.gov More Transfusion-dependent Thalassemia trials

Plain-language summary

Who can participate

Age range

3 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.