SEQUENTIAL DEFERASIROX-DEFERIPRONE VERSUS DEFERASIROX OR DEFERIPRONE MULTICENTRE RANDOMIZED TRIAL - ND

Phase 1

• Conditions: BETA-THALASSEMIA MAJOR; MedDRA version: 12.0Level: LLTClassification code 10004514Term: Beta-thalassaemia

• Registration Number: EUCTR2009-014666-25-IT
• Lead Sponsor: FONDAZIONE FRANCO E PIERA CUTINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-30
• Last Update Posted: 30 April 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 363

Inclusion Criteria

1.MALE AND FEMALE, AGE &#8805;12 AND <50 YEARS OLD;
2.DIAGNOSIS OF BETA-THALASSEMIA MAJOR;
3.SERIC FERRITIN CONCENTRATION &#8805;1.000 ?g/l.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.DIAGNOSIS OTHER THEN BETA-THALASSEMIA MAJOR;
2.PATIENTS WITH RENAL FAILURE (CREATININE CLEARANCE < 60 ml/min;
3.ALT/AST >300 U/L ;
4.SEVERE CARDIOMYOPATHY;
5.PATIENTS WITH PREVIOUS SIGNIFICATIVE OCULAR TOXICITY RELATED TO IRON CHELATING DRUGS;
6.PATIENTS WITH PREVIOUS SIGNIFICATIVE IDIOSYNCRASIC REACTION OR SEVERE TOXICITY TO PREVIOUS THERAPY WITH DEFERIPRONE OR DEFERASIROX;
7.PLATELETES < 100.000/mmc;
8.LEUKOCYTES <3000/mm;
9.SEVERE LIVER INSUFFICIENCY(Child-Pugh SCORE C).

Study & Design

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