THETIS- Efficacy and Safety Study of Deferasirox in Patients With Non-transfusion Dependent Thalassemia

Phase 4

• Conditions: on-transfusion Dependent Thalassemia; Non-transfusion Dependent Thalassemia; D56.9

• Registration Number: LBCTR2020011375
• Lead Sponsor: ovartis Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2013-12-31
• Study Start: 2020-01-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Non-transfusion dependent congenital or chronic anemia inclusive of beta-thalassemia intermedia, HbE beta-thalassemia or alpha-thalassemia intermedia (HbH disease)/ Liver iron concentration >/= 5 mg Fe/g dw Serum Ferritin >/= 300 ng/m

Exclusion Criteria

HbS-beta Thalassemia, anticipated regular transfusion program during the study, blood transfusion 6 months prior to study start, significant proteinuria..

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ame: Absolute change in liver iron concentration measured by MRI;Timepoints: baseline, 52 weeks;Measure: baseline, 52 weeks

Secondary Outcome Measures

Name	Time	Method
ame: •Percentage of Participants With Baseline LIC more than 15 Achieving LIC less than 5 mg ;Timepoints: 5 years;Measure: 5 years;Name: •Time to Achieving LIC less than 5 mg ;Timepoints: 5 years ;Measure: 5 years