Phase-3, Multicentric, open label trial to evaluate the efficacy of Hydroxyurea and Thalidomide in Thalassemia patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- DGAFMS
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 1. Blood transfusion pre and post intervention in ml/kg/month
研究概览
简要总结
This study aims to explore the effectiveness of hydroxyurea and thalidomide in the treatment of transfusion dependent thalassemia (TDT) to improve the haemoglobin level, improve the quality of life, reduce blood transfusion, so as to avoid the adverse reactions caused by transfusion.
The project is a multi-arm, multicentric research of hydroxyurea and thalidomide in transfusion-dependent thalassemia patients. Patients volunteering to participate in this trial and meeting the inclusion criteria will be enrolled. Participants will be randomised to either hydroxyurea or thalidomide or both hydroxyurea and thalidomide or standard of care arm. 40 patients will be allocated to each group and the estimated duration of study is 03 years. Dosage of hydroxyurea will be up to 15 mg/kg and thalidomide up to 3 mg/kg along with aspirin 5mg per kg per day. During this time, hepatic and renal function, hematologic function, electrocardiogram and the adverse reactions will be closely observed and blood transfusion will be done if hemoglobin levels is below 8 g/dl.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 4.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of transfusion-dependent thalassemia
- •ECOG: 0 to 2 scores
- •Blood transfusion to maintain the Hb or level of Hb<9g/dl if not transfused
- •Sign an informed consent agreeing to the clinical trial participation.
排除标准
- •Patients with comorbidities like severe heart or lung diseases, liver dysfunction, renal dysfunction, malignancy, cerebrovascular disease, or other serious primary diseases
- •Patients allergic to the drug ingredients
- •Patients with any mental health problem
- •Patients had participated in other drug clinical trials in the past 1 month
- •Patients had a history of venous or arterial thrombosis
- •Childbearing age unwilling to use contraceptive measures
- •In certain circumstances the researchers determined it was not suitable for the research.
结局指标
主要结局
1. Blood transfusion pre and post intervention in ml/kg/month
时间窗: at 06 months
次要结局
- 1. Serum Ferritin pre and post intervention(2. Nadir Hemoglobin pre and post intervention)