Combining Hydroxyurea and Thalidomide for Treating Children with Thalassemia
Efficacy of Combination of Hdroxyurea and Thalidomide Over Either Hydroxyurea or Thalidomide Alone in the Treatment of Transfusion Dependent Thalassemia in Children: A Quasi-Randomised Clinical Trial
This study is testing if using Hydroxyurea and Thalidomide together can help children with thalassemia who need regular blood transfusions feel better compared to using just one of the drugs alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT06299670 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of combining Hydroxyurea and Thalidomide compared to using either drug alone in treating children with transfusion-dependent thalassemia. The study aims to address the limitations of current treatments, particularly the challenges associated with hematopoietic stem cell transplantation. By inducing fetal hemoglobin production and reducing inflammation, the combination therapy seeks to improve patient outcomes. The trial includes children aged 3 to 18 who have been dependent on blood transfusions for over a year.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 to 18 diagnosed with transfusion-dependent thalassemia who have required blood transfusions for more than a year.
Not a fit: Patients with active systemic co-morbidities or a history of thrombophilia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective alternative for managing transfusion-dependent thalassemia in children.
How similar studies have performed: Previous studies have shown promising results with the combination of Hydroxyurea and Thalidomide, although many were retrospective or non-randomized.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dhaka
- Bangabandhu Sheikh Mujib Medical University — Dhaka, Bangladesh (Recruiting)
Study contacts
- Study coordinator: Md. Anwarul Karim, MBBS,FCPS, MD
- Email: drkarim1990@gmail.com
- Phone: +880255165814
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.