Thalassaemia
Conditions
Interventions
Experimental Arm:Thalidomide 100-150 mg qd po, adjusted according to adverse effects.
Placebo Arm:Placebo 100-150 mg qd po
Sponsors
Wuzhou Gongren Hospital, Guangxi Zhuang Autonomous Region
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Beta-thalassemia as confirmed by DNA testing and clinical manifestations; 2. Aged above 14 years old, Ecog status between 0~3; 3. Transfusion independent to maintain a hemoglobin level above 60g/L before study entry; 4. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted; 5. Estimated survive time above 3 months; 6. Rule out other possible anemia causes; 7. Subject with suitable liver and renal function.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Received EPO, Yisheng Shengxue Particles, hydroxyurea, thalidomide, decitabine, azacitidine, butyrate treatment within 3 months before study entry; 2. With severe cardiopulmonary and/or renal insufficiency complications; 3. With cardiovascular,cerebrovascular and/or neoplastic complications; 4. Arteriovenous thrombosis within 3 months before study entry; 5. Combined with other causes of anemia; 6. Diagnosed as psychiatric disorder; 7. Unfit for oral medications; 8. Currently pregnant or lactating or wowen of childbearing age but unwilling to take contraceptive measures; 9. Allergic to the medications. Participants that work as pilots, drivers and/or machine operators during the trial; 10. Participants of other clinical trials; 11. Any conditions that investigators consider as unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin electrophoresis;Blood transfusion;Total bilirubin;Indirect bilirubin;Lactate dehydrogenase;Reticulocyte count;Peripheral nucleated red blood cell count; | — |
Countries
China
Contacts
Public ContactJiangming Chen
Wuzhou Gongren Hospital, Guangxi Zhuang Autonomous Region
Outcome results
None listed