drugset / Trial / NCT02041299

Efficacy and Safety of Ferriprox® in Patients With Sickle Cell Disease or Other Anemias

NCT02041299 ↗

Phase 4 Terminated 230 enrolled ApoPharma
RandomizedParallel-groupOpen-labelTreatment

Summary

This research is being done so that we can look at the safety and efficacy of deferiprone in people with sickle cell disease or other anemias. Deferiprone is a drug that removes iron from the body. We will be comparing deferiprone with deferoxamine, another drug that removes iron from the body.

Timeline

Start
2014-04-17
Primary completion
2019-04-20
Completion
2019-06-18

Outcome

Met primary endpoint

Stopped (Enrollment): “Difficulties with additional recruitment as pool of potential patients was exhausted, and sufficient information for determination of study outcome measure was already obtained”

paper with noninferiority of deferiprone to deferoxamine demonstrated by analysis of covariance (least squares mean difference 0.40 [0.56]; 96.01% confidence interval, -0.76 to 1.57). PMID 34847228 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Deferiprone Small molecule 25 mg/kg Oral
Subject Deferiprone Small molecule 33 mg/kg Oral
Comparator Deferoxamine Other / unclassified 20 mg/kg Subcutaneous
Comparator Deferoxamine Other / unclassified 40 mg/kg Subcutaneous
Comparator Deferoxamine Other / unclassified 50 mg/kg Subcutaneous