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Efficacy of thalidomide in a blood disorder requiring repeated blood transfusions

Efficacy of thalidomide in transfusion dependent thalassemia: a randomized double blind placebo controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/072981
Enrollment
56
Registered
2024-08-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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: Dose 2-3 mg/kg/day for 6 months Control Intervention1: placebo: 2-3 mg/kg/day for 6 months

Sponsors

Vineeta Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both genders would be selected Transfusion dependent Homozygous beta thalassemia HbE beta thalassemia Hydroxy urea refractory

Exclusion criteria

Exclusion criteria: Pregnant/planning pregnancy/lactating females Hepatitis B,C and HIV positive patients Patients with renal, cardiac, liver disease History of cerebrovascular accidents Splenectomized patients

Design outcomes

Primary

MeasureTime frame
Number of blood transfusions required after thalidomide interventionTimepoint: baseline, 3 months, 6 months

Secondary

MeasureTime frame
Rate of fall of hemoglobin Change in RBC indices Change in serum ferritin, LDH and uric acid levels Documentation of side effectsTimepoint: 6 months

Countries

India

Contacts

Public ContactVineeta Gupta

Department of Pediatrics, Institute of Medical Sciences,, BHU

rekhasrivaraprasad937@gmail.com7538854746

Outcome results

None listed

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