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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014666-25-IT

Enrollment

363

Registered

2009-07-30

Start date

2010-01-02

Completion date

Unknown

Last updated

2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BETA-THALASSEMIA MAJOR MedDRA version: 12.0 Level: LLT Classification code 10004514 Term: Beta-thalassaemia

Interventions

Trade Name: EXJADE Pharmaceutical Form: Tablet INN or Proposed INN: DEFERASIROX Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 30- Trade Name: FERRIP

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.MALE AND FEMALE, AGE &#8805;12 AND =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.DIAGNOSIS OTHER THEN BETA-THALASSEMIA MAJOR; 2.PATIENTS WITH RENAL FAILURE (CREATININE CLEARANCE 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).

Design outcomes

Primary

Measure	Time frame
Main Objective: CHELATING EFFICACY ASSESSMENT OF SEQUENTIAL THERAPY DEFERASIROX-DEFERIPRONE VERSUS DEFERASIROX OR DEFERIPRONE ALONE.;Secondary Objective: 1.TO ASSESS IN THE SEQUENTIAL DEFERASIROX-DEFERIPRONE TREATED GROUP A REDUCTION AT LEAST IN 50% OF CASES OF CREATININEMIA SIGNIFICATIVE INCREASE (>33%) COMPARED TO THE DEFERASIROX ALONE GROUP; 2.TO ASSESS IN THE SEQUENTIAL DEFERASIROX-DEFERIPRONE TREATED GROUP A REDUCTION AT LEAST IN 70% OF CASES OF NEUTROPENIA COMPARED TO THE DEFERIPRONE ALONE GROUP; 3.TO ASSESS, USING MAGNETIC RESONANCE IMAGING, IN A SUBGROUP, THE POSSIBLE ORGAN-SPECIFIC (HEART, LIVER, PANCREAS) IRON OVERLOAD VARIATION DURING THERAPY.;Primary end point(s): CHELATING EFFICACY ASSESSMENT OF SEQUENTIAL THERAPY DEFERASIROX-DEFERIPRONE VERSUS DEFERASIROX OR DEFERIPRONE ALONE.	—

Measure

Time frame

Main Objective: CHELATING EFFICACY ASSESSMENT OF SEQUENTIAL THERAPY DEFERASIROX-DEFERIPRONE VERSUS DEFERASIROX OR DEFERIPRONE ALONE.;Secondary Objective: 1.TO ASSESS IN THE SEQUENTIAL DEFERASIROX-DEFERIPRONE TREATED GROUP A REDUCTION AT LEAST IN 50% OF CASES OF CREATININEMIA SIGNIFICATIVE INCREASE (>33%) COMPARED TO THE DEFERASIROX ALONE GROUP; 2.TO ASSESS IN THE SEQUENTIAL DEFERASIROX-DEFERIPRONE TREATED GROUP A REDUCTION AT LEAST IN 70% OF CASES OF NEUTROPENIA COMPARED TO THE DEFERIPRONE ALONE GROUP; 3.TO ASSESS, USING MAGNETIC RESONANCE IMAGING, IN A SUBGROUP, THE POSSIBLE ORGAN-SPECIFIC (HEART, LIVER, PANCREAS) IRON OVERLOAD VARIATION DURING THERAPY.;Primary end point(s): CHELATING EFFICACY ASSESSMENT OF SEQUENTIAL THERAPY DEFERASIROX-DEFERIPRONE VERSUS DEFERASIROX OR DEFERIPRONE ALONE.

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026