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

Phase 1

• Conditions: MedDRA version: 14.1 Level: HLT Classification code 10022979 Term: Iron excess System Organ Class: 100000004861; iron overload in patients with non-transfusion dependent thalassemia; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-000650-64-GR
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-21
• Study Completion: 2019-01-17
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 134

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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