transfusion-dependent thalassemia transfusion-dependent thalassemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Transfusion-dependent homozygous beta-thalassemia or beta-thalassemia/Hb E (2) Hemoglobin concentration 5-9 g/dl (3) Serum ferritin level > 1000 ng/ml
Exclusion criteria
Exclusion criteria: (1) Lactation or pregnancy (2) ALT, AST > 3 times of the upper limit of normal, Creatinine > 2 mg/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Iron parameters Total 7 time points : (1) Baseline, (2) Week 12th, (3) Week 24th, (4) Week 36th, (5) Week 48th, (6) Week 60th, and (7) Week 72th of the study Automated chemistry analyzer/Colorimetric method,Inflammatory parameters Total 7 time points : (1) Baseline, (2) Week 12th, (3) Week 24th, (4) Week 36th, (5) Week 48th, (6) Week 60th, and (7) Week 72th of the study Particle enhanced immunoturbidimetry/Multiplex cytokine assay,Oxidative stress parameters Total 7 time points : (1) Baseline, (2) Week 12th, (3) Week 24th, (4) Week 36th, (5) Week 48th, (6) Week 60th, and (7) Week 72th of the study Thiobarbituric acid assay/Colorimetric assay,D-dimer Total 7 time points : (1) Baseline, (2) Week 12th, (3) Week 24th, (4) Week 36th, (5) Week 48th, (6) Week 60th, and (7) Week 72th of the study Two-step enzyme immunoassay sandwich method | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete blood count Total 7 time points : (1) Baseline, (2) Week 12th, (3) Week 24th, (4) Week 36th, (5) Week 48th, (6) Week 60th, and (7) Week 72th of the study Automated blood cell analyzer ,Liver and renal function tests Total 7 time points : (1) Baseline, (2) Week 12th, (3) Week 24th, (4) Week 36th, (5) Week 48th, (6) Week 60th, and (7) Week 72th of the study Automated chemistry analyzer | — |
Countries
Thailand
Contacts
Department of Biochemistry, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand