drugset / Trial / NCT04741542
Safety of SP-420 in the Treatment of Transfusional Iron Overload
Phase 1
Terminated
2 enrolled
The University of Texas Health Science Center at San Antonio
Abfero Pharmaceuticals, Inc · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study enrolls patients with myelodysplastic syndrome (MDS) and myelofibrosis (MFS), with transfusional iron overload and treats them with the investigational iron chelator, SP-420. SP-420 may be better tolerated and safer than commercially available iron chelators. Iron chelation therapy (ICT) has been shown to improve outcomes in iron overload, but adherence is poor due to problems related to ease of administration, tolerability, and safety.
Timeline
- Start
- 2021-03-09
- Primary completion
- 2024-01-10
- Completion
- 2024-01-10
Outcome
Outcome not reported
Stopped: “Study is on hold by FDA in the US.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SP-420 | Small molecule | 14 mg/kg | Oral |
| Subject | SP-420 | Small molecule | 28 mg/kg | Oral |
| Subject | SP-420 | Small molecule | 42 mg/kg | Oral |
| Subject | SP-420 | Small molecule | 56 mg/kg | Oral |