drugset / Trial / NCT02041299
Efficacy and Safety of Ferriprox® in Patients With Sickle Cell Disease or Other Anemias
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |