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Comparing the Effectiveness and Safety of Single Drug Therapy with Deferasirox and Combined Therapy with Deferasirox and Deferiprone in lowering the level of Serum Ferritin in blood transfusion dependent children with Thalassemia and Anaemia.

Efficacy and Safety Profile of Deferasirox Monotherapy and Dual Therapy (Deferasirox plus Deferiprone) on Serum Ferritin Decline in Transfusion Dependent Pediatric Patients with Thalassemia and Chronic Hemolytic Anaemia. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/111723
Enrollment
74
Registered
2026-06-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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: Nil: Nil Intervention2: Nil: Nil

Sponsors

Father Muller Research Center
Lead Sponsor

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

MeasureTime frame
Change in serum ferritin from baseline to 12 months.Timepoint: Baseline, 3, 6, 9, 12 months

Secondary

MeasureTime 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

Public ContactDR Annie Samuel

Father Muller Medical College

smilekha25@gmail.com9743701662

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026