Effect of Jadenu®?and Exjade®?on reducing liver and heart iron overload in Beta-Thalassemia Major and Intermedia

A comparison study of the effects of Jadenu®?(Deferasirox) film-coated tablets and Exjade®?(Deferasirox) tablets for oral suspension on reducing liver and heart iron overload in patients with Beta-Thalassemia Major and Intermedia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210830052346N1

Enrollment

Registered

2021-11-09

Start date

2021-11-09

Completion date

Unknown

Last updated

2021-11-29

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

Conditions

Beta Thalasemia major. Beta thalassemia

Interventions

Intervention 1: Intervention group: The group that receives Jadenu. Jadenu is part of the drug class deferasirox . 33 people are being treated with Deferasirox (Jadenu®) for 6 months. This drug will

Eligibility

Sex/Gender

All

Age

2 Years to 50 Years

Inclusion criteria

Inclusion criteria: Age over 2 years old patients with Beta-Thalassemia Major and Intermedia Serum ferritin above 1000 µg / mL Having informed consent to enter the study

Exclusion criteria

Exclusion criteria: Having contraindication to Jadenu®?and Exjade®? Patients with GFR ?40 mL / min / 1.73 m^2 Patients with stunted growth Patients with High-risk myelodysplastic syndromes (MDS) malignant cancer patients with platelet lower than 50x 10^9/L Patients with prior knowledge of allergy to drugs of the defrazirox group Patients with liver failure Patients with gastrointestinal bleeding Patients with renal failure Using other iron chelators at the same time age over 50 years old

Design outcomes

Primary

Measure	Time frame
Cardiac iron load. Timepoint: At the beginning of the study and 6 months after taking Exjade or Jadenu. Method of measurement: T2MRI.;Liver iron load. Timepoint: At the beginning of the study and 6 months after taking Exjade or Jadenu. Method of measurement: T2MRI.;Aspartate aminotransferase(AST). Timepoint: At the beginning of the study and 2, 4 and 6 months after taking Exjade or Jadenu. Method of measurement: The patient's serum is separated by centrifugation and given to an autoanalyzer.;Alanine transaminase(ALT). Timepoint: At the beginning of the study and 2, 4 and 6 months after taking Exjade or Jadenu. Method of measurement: The patient's serum is separated by centrifugation and given to an autoanalyzer.	—

Measure

Time frame

Cardiac iron load. Timepoint: At the beginning of the study and 6 months after taking Exjade or Jadenu. Method of measurement: T2*MRI.;Liver iron load. Timepoint: At the beginning of the study and 6 months after taking Exjade or Jadenu. Method of measurement: T2*MRI.;Aspartate aminotransferase(AST). Timepoint: At the beginning of the study and 2, 4 and 6 months after taking Exjade or Jadenu. Method of measurement: The patient's serum is separated by centrifugation and given to an autoanalyzer.;Alanine transaminase(ALT). Timepoint: At the beginning of the study and 2, 4 and 6 months after taking Exjade or Jadenu. Method of measurement: The patient's serum is separated by centrifugation and given to an autoanalyzer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactVahid falahati

Arak University of Medical Sciences

mahya.mobini@yahoo.com+98 86 3277 5382

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026