Health Condition 1: D561- Beta thalassemia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 2-18 years Transfusion dependent thalassemia and transfusion dependent chronic haemolytic anaemia cases including sickle cell anaemia pyruvate kinase deficiency anaemia glucose phosphate isomerase deficiency anaemia who are transfusion dependent with serum ferritin more than 1000ng per ml with parental consent and assent after obtaining clearance from Institutional Ethics Committee
Exclusion criteria
Exclusion criteria: 1 Severe organ impairment with deranged LFT and RFT 2 Active infection 3 History of agranulocytosis and neutropenia 4 Non compliance to therapy 5 Patients on triple iron chelation therapy or parentral deferoxamine DFO therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum ferritin from baseline to 12 months.Timepoint: Baseline, 3, 6, 9, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Adverse events (gastrointestinal, hepatic, renal, auditory/ocular, neutropenia) 2.Compliance (pill count): Criteria for drug compliance will be more than 25 pills/ month, for both the drugs. 3.Hemoglobin levels 4.Transfusion requirements Timepoint: Baseline, 3, 6, 9, 12 months | — |
Countries
India
Contacts
Father Muller Medical College