Tests SP-420 for removing iron from organs in certain blood disorders
Tests SP-420 to remove excess iron in adults with thalassemia or myelodysplastic syndrome.
Plain-language title generated from the registry record
Registry title: A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes
Key facts
- Where
- Bologna, Cagliari, Florence, Genoa, Milan, Modena, Naples, and Pavia, ItalySee the 10 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT05693909, who can take part
Where in Italy
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- ARNAS G. BrotzuCagliari, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Ente Ospedaliero Ospedali Galliera Di GenovaGenoa, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pharmacosmos A/S
- Trial code
- NCT05693909EU 2023-507396-21-00
- Record updated
- 24 September 2025
- Original description
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.Read full original descriptionShow less
An Open-label, Dose-escalation, Dose-finding, and Proof-of-concept Trial of SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes
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
Inclusion: Women and men aged 18 years or older; Transfusion-dependent β-thalassemia including HbE/β-thalassemia requiring iron chelation therapy (β-thalassemia with mutation and/or multiplication of α-globin is allowed); On a stable dose of iron chelation for at least 4 weeks prior to screening; Weight ≥ 35kg at screening; Transfusion iron overload; Treated and followed for at least the past 6 months in a specialized centre; Women and men aged 18 years or older; Very low, low, or intermediate risk Myelodysplastic Syndrome according to IPSS-R; Weight ≥ 35kg at screening; Transfusion iron overload; Treated and followed for at least the past 6 months at medical facilities experienced with MDS.
Exclusion: Therapy-related MDS or MDS with a known bone marrow fibrosis; Major surgery within 8 weeks prior to screening; Current biliary disorder; Historic or ongoing clinically significant kidney disease; Men who do not agree to practice effective barrier contraception during the entire period; Myelodysplastic Syndromes Cohorts:; Clinically significant kidney disease, either historic or ongoing; Uncontrolled ischemic heart disease or uncontrolled arrythmia; Uncontrolled hypertension; Uncontrolled Diabetes; β-thalassemia with the structural Hb variants HbS and HbC; Current MDS; Unable to undergo trial assessments including MRI e.g. due to claustrophobia in MRI scanner; Pregnant or nursing women; Diagnosis of decompensated liver cirrhosis; Uncontrolled dyslipidaemia; Pregnant or nursing women; Men who do not agree to practice effective barrier contraception during the entire period.
Thalassemia cohorts:.