Thalidomide and Hydroxyurea as add-on therapy in patients diagnosed with transfusion dependent and non-transfusion dependent Thalassemia – a multicenter randomized placebo-controlled trial. - NI

Indian Council of Medical research [ICMR], New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1. Adults and children of any gender aged 12 years and above, willing to provide a written informed consent.
•2. Diagnosis of TDT patients requiring regular blood transfusion for survival
•3. Diagnosis of NTDT who is requiring at least 4-6 units of PRBC in the last 24 weeks working definition of NTDT for this study, which is jointly agreed by all investigators
•4. Willing to follow the study protocol
•5. Eastern Cooperative Oncology Group ECOG performance status 1-2

•1. Patients who are critically ill as judged by physician
•2. Patients with comorbidities like severe heart or lung diseases, liver dysfunction, renal dysfunction, malignancy, cerebrovascular disease, or other serious primary diseases
•3. Those with past personal or family history of thrombophilia and recent splenectomy within 3 months, Absolute neutrophil count (ANC) less than 2000/ mm3 in the 8 weeks before study entry or a history of chronic neutropenia, defined as an ANC less than 2000/mm3.
•4. Platelet count less than 100,000/mm3 or greater than 1,000,000/mm3 in the 8 weeks before study entry.
•5. History of allergy to the drug ingredients
•6. Participation in other drug clinical trials in the past 1 month
•7. History of venous or arterial thrombosis
•8. Known case of Human Immunodeficiency Virus, active Hepatitis C infection or Hepatitis B infection
•9. Women who are pregnant or breast feeding or women of childbearing potential not willing to follow double contraceptive measures
•10. Patients who are already receiving hydroxyurea/study drugs as standard of care
•11. Any other reason that in the opinion of the investigator is likely to cause harm to the participant or will adversely affect the results of the study.

发起方

Indian Council of Medical research [ICMR], New Delhi