Thalassemia in Children: Studying Thalidomide Alone vs With Hydroxyurea

A clinical trial to study the effects of Thalidomide Versus Combined Thalidomide and Hydroxyurea among children with transfusion dependent thalassemia. - Nil

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089049

Enrollment

Registered

2025-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: D561- Beta thalassemia

Interventions

Intervention1: Thalidomide + Hydroxyurea : Thalidomide 2.5mg/kg/day oral + Hydroxyurea 10mg/kg/day, oral form12 months Control Intervention1: Thalidomide: Thalidomide 2.5mg/kg/day, oral form12 months

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children more than 5 years diagnosed with transfusion-dependent thalassemia and on regular transfusion at our institute. 2.Patients with an ECOG performance status of 0 to 3.Patients who agree to receive thalidomide treatment and to sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Children less than 5 years, 2. Significant comorbidities e.g. Hypertension/Thyroid disease/Metabolic disorders /Autoimmune diseases /Chronic Diseases of the GIT/Liver/Kidney/Cardiac /Neurological Diseases 3. Hypersensitivity to study drugs 4. Consent not given

Design outcomes

Primary

Measure	Time frame
Reduction in transfusion requirements (measured as units of blood transfused over 12 months). oSecondary Outcomes: Hemoglobin levels, fetal hemoglobin percentage, adverse events, and quality of life (measured using a validated questionnaire).Timepoint: Reduction in transfusion requirements (measured as units of blood transfused over 12 months). oSecondary Outcomes: Hemoglobin levels, fetal hemoglobin percentage, adverse events, and quality of life (measured using a validated questionnaire).	—

Measure

Time frame

Reduction in transfusion requirements (measured as units of blood transfused over 12 months). oSecondary Outcomes: Hemoglobin levels, fetal hemoglobin percentage, adverse events, and quality of life (measured using a validated questionnaire).Timepoint: Reduction in transfusion requirements (measured as units of blood transfused over 12 months). oSecondary Outcomes: Hemoglobin levels, fetal hemoglobin percentage, adverse events, and quality of life (measured using a validated questionnaire).

—

Secondary

Measure	Time frame
Hemoglobin levels, fetal hemoglobin percentage, adverse events, and quality of life (measured using a validated questionnaire).Timepoint: at 3 months,6 months and 12 months	—

Countries

India

Contacts

Public ContactDr Shweta PathaK

Netaji Subhash Chandra Bose Medical College

drsp83@gmail.com8085577637

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026