The effectiveness of drug combination in patients with beta-thalassemia major and severe iron overload

A clinical trial comparing the effectiveness of deferoxamine–deferasirox, deferasirox–deferiprone, and deferoxamine–deferiprone combinations in patients with beta-thalassemia major and severe iron overload

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251214068323N1

Enrollment

105

Registered

2026-01-07

Start date

2026-01-21

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-thalassemia major. Beta thalassaemia

Interventions

Intervention 1: Intervention Group 1: Patients in this group will receive Deferasirox (oral tablet, 14–28 mg/kg once daily for at least six months). Deferasirox is an oral iron chelator manufactured

Eligibility

Sex/Gender

All

Age

5 Years to 18 Years

Inclusion criteria

Inclusion criteria: Children with beta-thalassemia major and severe iron overload who have not achieved adequate iron control with monotherapy. Age above 5 years Severe iron overload defined as serum ferritin greater than 2500 ng/dl or severe/very severe iron overload reported in cardiac and hepatic MRI Absence of congenital heart disease Absence of chronic viral hepatitis infection Absence of heart failure

Exclusion criteria

Exclusion criteria: Having chronic infectious diseases such as hepatitis Serum creatinine level increased by more than 25% above baseline Having proteinuria ALT level elevated more than five times the normal value Having study drugs allergies

Design outcomes

Primary

Measure	Time frame
Cardiac iron concentration. Timepoint: 12 months after intervention. Method of measurement: Magnetic resonance imaging (MRI).;Serum ferritin levels. Timepoint: 1, 2 and 3 months after intervention. Method of measurement: ELISA Ferritin Assay Kit.;Hepatic iron concentration. Timepoint: 12 months after intervention. Method of measurement: Magnetic resonance imaging (MRI).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Farhangi

Mashhad University of Medical Sciences

farhangih@mums.ac.ir+98 51 3727 3943

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026