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A Multicentric, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of Thalidomide in Adults and Adolescents with Transfusion-Dependent ß-thalassemia Major/Intermediate

A Multicentric, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of Thalidomide in Adults and Adolescents with Transfusion-Dependent ß-thalassemia Major/Intermediate

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015702
Enrollment
Unknown
Registered
2018-04-16
Start date
2018-04-23
Completion date
Unknown
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thalassaemia

Interventions

Experimental Arm:thalidomide 100-150 mg/time/day

Sponsors

Wuzhou Gongren Hospital, Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

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: 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 women 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

MeasureTime frame
Hemoglobin;Hemoglobin electrophoresis;Blood transfusion;Total bilirubin;Indirect bilirubin;Lactate dehydrogenase;Reticulocyte count;Peripheral nucleated red blood cell count;RNA-Seq;Aspartate aminotransferase;Alanine aminotransferase;Creatinine;Urea nitrogen;Erythrocyte life span;

Countries

China

Contacts

Public ContactJiangming Chen

Wuzhou Gongren Hospital, Guangxi Zhuang Autonomous Region

jiangming.chen@126.com+86 13878403609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026