Clinical Trial

A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes

Recruiting Phase 2

Summary

The goal of this clinical trial is to learn about SP-420 ability to remove iron from organs in subjects with transfusion-dependent β-thalassemia or transfusion-dependent low-risk myelodysplastic syndrome. The main questions it aims to answer are: * How efficient is SP-420 in cleaning iron from the liver? * How is the safety and tolerability of ascending doses of SP-420? Participants will: * Take medication three times weekly * Attend up to 20 site visits * Undergo MRI scans

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2023-01-20; most recent amendment 2025-09-19.

Status change: Not Yet Recruiting → Recruiting 2023-10-18

Trial Details

NCT Number	NCT05693909
Lead Sponsor	Pharmacosmos A/S Collaborators: ICON plc
Conditions	Beta Thalassemia Major Anemia, Myelodysplastic Syndrome
Enrollment	90 participants
Start Date	2023-09-04
Primary Completion	2027-10 (estimated)
Study Completion	2028-05 (estimated)
Updated on ClinicalTrials.gov	2025-09-24