Unraveling the Impact of Thalidomide at Diverse Doses in Transfusion Dependent Beta Thalassemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-35
SponsorNational Institute of Blood and Marrow Transplant (NIBMT), Pakistan

About this trial

The project "Unraveling the Impact of Thalidomide at Diverse Doses in Transfusion Dependent Beta Thalassemia" investigates the safety and efficacy of low-dose thalidomide in managing beta thalassemia, a genetic disorder causing anemia. Conducted over two years at NIBD hospital, the study involves 54 transfusion-dependent patients aged 8-35. The primary objective is to correlate thalidomide doses with disease severity, adverse effects, and treatment response, aiming to optimize treatment strategies and reduce side effects.

Data will be collected through clinical interviews and medical record reviews and analyzed using SPSS. Key variables include hemoglobin levels, leukocyte and reticulocyte counts, platelets, liver and spleen size, genetic modifiers, and transfusion frequency. Inclusion criteria are specific to beta thalassemia patients, while exclusion criteria rule out those with liver dysfunction, married patients, lactating mothers, and those with a history of thrombosis or fits.

Eligibility criteria

Qualifiers

Know case of beta thalassemia major/ intermediate ( transfusion dependent)

willing to give informed consent

Disqualifiers

Patients with comorbidities such as liver dysfunction

Married patients

Lactating mother

H/O thrombosis and fits

Trial design

Treatments tested in this trial

  • Thalidomide
  • Thalidomide

Treatment groups

54 Participants
are divided into 3 treatment groups

Sponsors and collaborators

National Institute of Blood and Marrow Transplant (NIBMT), Pakistan

Lead sponsor

National Institute of Blood Disease Center, Pakistan

Sponsor institution