Comparison Of Efficacy And Safety Of Thalidomide Vs Hydroxyurea In Thalassemia Patients: A Single-Centre Pilot Study.
- Registration Number
- NCT06239389
- Lead Sponsor
- National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
- Brief Summary
The goal of this study is to compare the effectiveness and safety of two hemoglobin F inducer. This is single centered interventional pilot study is to compare the efficacy and safety parameters in beta thalassemia patients. As this is a pilot study, the investigator took a small number of patients. The Sample size was calculated by the World health organization sample size calculator. After screening 39 patients and 24 patients were eligible for enrollment in this study.
The main objective was to evaluate safety of both drugs in genetic disorder like thalassemia. for safety evaluation, hematological parameters were evaluated that includes total bilirubin , indirect bilirubin, Serum Glutamate Pyruvate Transaminase, serum glutamic-oxaloacetic transaminase, urea, creatinine and lactate dehydrogenase were monitored . Moreover to evaluate the efficacy of drug, hematological parameters that includes hemoglobin, red blood cells , nucleated red blood cells , reticulocytes count, Red blood cells indices ( mean corpuscular hemoglobin, mean corpuscular volume and mean corpuscular hemoglobin concentration) , white blood cells and platelets were done. Another important parameters to evaluate the efficacy of hemoglobin F inducer is transfusion frequency.
Test were done at baseline and after completion of study means after 06 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Know case of beta thalassemia age between 10-30 years
- Patients on any other haemoglobin F inducer or erythropoietin.
- Patients with co-morbidities like cardiopulmonary and neurological disease
- Pregnant, lactating women.
- Patient did not willing to take contraceptive measures.
- Participants with history of thrombosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description hydroxyurea Thalidomide 100mg Hydroxyurea is available in oral dosage form which is capsule. frequency: once a day duration: at every 24 hours dose: 15/mg/kg/day. Thalidomide Hydroxyurea Thalidomide is available in oral dosage form which is capsule. frequency: once a day at night duration: at every 24 hours dose:50 mg / day (in patients \>10-13 years) while the adult dose was 100 mg /day (age \>13 Years)
- Primary Outcome Measures
Name Time Method comparison of hemoglobin 06 months Hemoglobin
comparison of red blood cells 06 months Red blood cells
comparison of Mean Corpuscular Hemoglobin concentration 06 months Mean Corpuscular Hemoglobin concentration
comparison of Mean corpuscular volume 06 months Mean corpuscular volume
comparison of Mean Corpuscular Hemoglobin 06 months Mean Corpuscular Hemoglobin
comparison of Indirect bilirubin 06 months Indirect bilirubin
comparison of Total Bilirubin 06 months Total Bilirubin
comparison of Serum glutamic pyruvic transaminase 06 months Serum glutamic pyruvic transaminase
comparison of glutamic-oxaloacetic transaminase 06 months glutamic-oxaloacetic transaminase
comparison of white blood cells 06 months white blood cells
comparison of platelets 06 months Platelets
comparison of urea 06 months Urea
comparison of creatinine 06 months Creatinine
comparison of Lactate dehydrogenase baseline and after the completion of study. 06 months Lactate dehydrogenase
comparison of tranfusion frequency baseline and after the completion of study. 06 months Transfusion interval
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
National Institute of Blood Diseases and Bone Marrow Transplantation
🇵🇰Karachi, Sindh, Pakistan