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临床试验/NCT06239389
NCT06239389已完成2 期

Comparison Of Efficacy And Safety Of Thalidomide Vs Hydroxyurea In Thalassemia Patients: A Single-Centre Pilot Study.

National Institute of Blood and Marrow Transplant (NIBMT), Pakistan1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
comparison of Serum glutamic pyruvic transaminase

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Know case of beta thalassemia age between 10-30 years

排除标准

  • 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.

研究组 & 干预措施

hydroxyurea

Active Comparator

Hydroxyurea is available in oral dosage form which is capsule. frequency: once a day duration: at every 24 hours dose: 15/mg/kg/day.

干预措施: Thalidomide 100mg (Drug)

Thalidomide

Experimental

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)

干预措施: Hydroxyurea (Drug)

结局指标

主要结局

comparison of Serum glutamic pyruvic transaminase

时间窗: 06 months

Serum glutamic pyruvic transaminase

comparison of glutamic-oxaloacetic transaminase

时间窗: 06 months

glutamic-oxaloacetic transaminase

comparison of white blood cells

时间窗: 06 months

white blood cells

comparison of platelets

时间窗: 06 months

Platelets

comparison of urea

时间窗: 06 months

Urea

comparison of creatinine

时间窗: 06 months

Creatinine

comparison of Lactate dehydrogenase baseline and after the completion of study.

时间窗: 06 months

Lactate dehydrogenase

comparison of hemoglobin

时间窗: 06 months

Hemoglobin

comparison of red blood cells

时间窗: 06 months

Red blood cells

comparison of Mean Corpuscular Hemoglobin concentration

时间窗: 06 months

Mean Corpuscular Hemoglobin concentration

comparison of Mean corpuscular volume

时间窗: 06 months

Mean corpuscular volume

comparison of Mean Corpuscular Hemoglobin

时间窗: 06 months

Mean Corpuscular Hemoglobin

comparison of Indirect bilirubin

时间窗: 06 months

Indirect bilirubin

comparison of Total Bilirubin

时间窗: 06 months

Total Bilirubin

comparison of tranfusion frequency baseline and after the completion of study.

时间窗: 06 months

Transfusion interval

次要结局

未报告次要终点

研究者

发起方
National Institute of Blood and Marrow Transplant (NIBMT), Pakistan
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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