NCT05693909RecruitingPhase 2
A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes
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
Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 22 Dec 2022
- Start date
- 4 Sept 2023
- Primary completion date
- Oct 2027
- Lead sponsor
- Pharmacosmos A/S
- Diseases
- Myelodysplastic syndromes, Thalassaemia
- NCT number
- NCT05693909
- EU CT number
- 2023-507396-21-00
- EudraCT number
- 2022-002395-36
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 90
- From 4 Sept 2023 to the primary completion date, Oct 2027
- 28 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Therapy-related MDS or MDS with a known bone marrow fibrosis
- Major surgery within 8 weeks prior to screening
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Criteria the registry did not label
- Thalassemia cohorts:
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Midtjylland Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Hippokration Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Nosokomeio Paidon I Agia Sofia Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Recruiting |
| University General Hospital of Ioannina Coordinator of this site? Confirm its status | Ioannina | Greece | Recruiting |
| General Hospital Of Larissa Koutlibaneio And Triantafylleio Coordinator of this site? Confirm its status | Larissa | Greece | Recruiting |
| Olympion Therapeftirio General Clinic Of Patras S.A. Coordinator of this site? Confirm its status | Patra | Greece | Recruiting |
| Ippokratio General Hospital of Thessaloniki Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| ARNAS G. Brotzu Coordinator of this site? Confirm its status | Cagliari | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Ente Ospedaliero Ospedali Galliera Di Genova Coordinator of this site? Confirm its status | Genoa | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| Szpital Wojewodzki W Opolu Sp. z o.o. Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Recruiting |
| Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Coordinator of this site? Confirm its status | Walbrzych | Poland | Recruiting |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.