MedTrace Logo

Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients

NCT01825512 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 435

Last updated 2021-05-04

Study results available
· View outcomes & findings →

Summary

Multicentre, randomised, open label, non-inferiority active-controlled trial to evaluate efficacy and safety of a 12-months treatment with deferiprone (DFP) at dose of 75-100 mg/kg/day versus deferasirox (DFX) at dose of 20-40 mg/kg/day in paediatric patients (1 month \< 18 years old) affected by hereditary haemoglobinopathies and requiring frequent transfusions and chelation.

Conditions

  • Chronic Iron Overload

Interventions

DRUG

Deferiprone

Deferiprone 80 mg/mL oral solution

DRUG

Deferasirox

Deferasirox is used at the following dosage strengths: 125 mg, 250 mg and 500 mg

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Consorzio per Valutazioni Biologiche e Farmacologiche

    lead OTHER

Principal Investigators

  • Donato Bonifazi, Dr · Consorzio per Valutazioni Biologiche e Farmacologiche

  • Aurelio Maggio, MD · Ospedali Riuniti Villa Sofia-Cervello

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-17
Primary Completion
2017-09-21
Completion
2017-09-21

Countries

  • Albania
  • Cyprus
  • Egypt
  • Greece
  • Italy
  • Tunisia
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01825512 on ClinicalTrials.gov