An open label, multi-center, efficacy and safety study of deferasirox in iron overloaded patients with nontransfusion dependent thalassemia.(THETIS)

• Conditions: Iron overload in patients with non-transfusion dependent thalassemia; MedDRA version: 14.1Level: PTClassification code 10065973Term: Iron overloadSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-000650-64-IT
• Lead Sponsor: OVARTIS FARMA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-11
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Male or female aged = 10 years with non-transfusion-dependent congenital or chronic anemias inclusive of beta-thalassemia intermedia, HbE beta-thalassemia or alpha-thalassemia intermedia (HbH disease) • LIC = 5 mg Fe/g dw measured by R2 MRI at screening • Serum ferritin = 300 ng/mL at screening (two consecutive values at least 14 days apart from each other) • Written informed consent obtained prior to any screening procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 17
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

• HbS-beta Thalassemia • Anticipated regular transfusion program during the study • Any blood transfusion 6 months prior to study start • Significant proteinuria; creatinine clearance =40 ml/min; serum creatinine >ULN; ALT >5xULN

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified