The effect of Jadenu with Exjade in reducing serum ferritin levels in patients with beta thalassemia major and intermedia

Phase 3

Recruiting

• Conditions: Condition 1: major thalasemia. Condition 2: intermedia thalasemia.; Beta thalassemia; D56.1

• Registration Number: IRCT20210831052350N1
• Lead Sponsor: Arak University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Age over 2 years
Patients diagnosed with thalassemia major and intermedia
Having conscious satisfaction
Serum ferritin above 1000 µg / m

Exclusion Criteria

Existence of contraindications to the studied drugs (Exjade®) and (Jadenu®)
Patients with GFR ?40 mL / min / 1.73 m2
Patients with stunted growth
Patients at high risk for myelodysplasia syndrome (MDS)
Advanced cancer
Platelets below 50 x 109 / L
Patients with knowledge of sensitivity to drugs of the defrazirox group
Patients with liver failure
Patients with gastrointestinal bleeding
Patients with renal insufficiency
Simultaneous use of other iron chelators

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum ferritin. Timepoint: Sampling every two months. Method of measurement: The patient's serum is separated by centrifuge and given to an auto-analyzer.;Serum creatinine. Timepoint: Sampling every two months. Method of measurement: The patient's serum is separated by centrifuge and given to an auto-analyzer.;Serum BUN. Timepoint: Sampling every two months. Method of measurement: The patient's serum is separated by centrifuge and given to an auto-analyzer.