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Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children

NCT03591575 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-03-15

Study results available
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Summary

This study is looking at the effects of giving early treatment of deferiprone to young children with beta thalassemia who have started receiving regular blood transfusions but have not yet reached the criteria for starting on iron chelation therapy. Half the patients in the study will receive deferiprone, and the other half will receive placebo, for up to 12 months.

Conditions

  • Beta Thalassemia Major Anemia
  • Iron Overload

Interventions

DRUG

Deferiprone oral solution

Liquid formulation of deferiprone, with a concentration of 80 mg/mL

DRUG

Placebo

Liquid solution that matches deferiprone oral solution in appearance and taste

Sponsors & Collaborators

  • Chiesi Canada Corp

    lead INDUSTRY

Principal Investigators

  • Mohsen El Alfy, MD · Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2020-09-29
Completion
2020-09-29
FDA Drug
Yes

Countries

  • Egypt
  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

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 NCT03591575 on ClinicalTrials.gov