Study the effects of combination of Thalidomide and Hydroxyurea in patients diagnosed with Thalassemia

Phase 4

• Conditions: Health Condition 1: D561- Beta thalassemia

• Registration Number: CTRI/2024/07/071470
• Lead Sponsor: Indian Council of Medical research [ICMR], New Delhi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified