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Taking people in GreecePhase 2

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.

Key facts

Who runs it
Pharmacosmos A/S
Where
Athens, Chaïdári, Ioannina, Larissa, Patra, and Thessaloniki, GreeceSee the 9 sitesAlso in 3 other countries, 19 sites
Registry title
A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes
Status
Recruiting
Phase
Phase 2
People taking part
90 people, planned
Started
4 Sept 2023
Expected to end
May 2028
Type of study
Interventional, 6 groups
Treatments tested
  • SP-420
Record updated
24 September 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with transfusion-dependent β-thalassemia or low-risk myelodysplastic syndrome who have too much iron in the body from blood transfusions.

Age
18 to 64 years
Sex
Women and men can join.
Disease stage
Transfusion-dependent β-thalassemia (including HbE/β-thalassemia) on iron chelation, or very low, low or intermediate risk myelodysplastic syndrome (IPSS-R). Both groups must have iron overload from transfusions.
Earlier treatment
Thalassemia group: a stable dose of iron chelation for at least 4 weeks before screening. Both groups: treated and followed for at least the past 6 months.

Main reasons for not taking part

  • Weight under 35kg (77 lb (35 kg))
  • Pregnant or nursing women
  • Clinically significant kidney disease, past or current
  • Unable to have MRI scans, for example because of claustrophobia
  • Thalassemia group: structural Hb variants HbS and HbC, current MDS or a current biliary disorder; MDS group: therapy-related MDS, bone marrow fibrosis or decompensated liver cirrhosis

The registry criteria, word for word

Show all 29 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Other criteria

  • Thalassemia cohorts:

Check if you might fit

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?

Where in Greece

Also in 3 other countries, 19 sites

  • Hippokration HospitalAthens, GreeceTaking people
  • Laiko General Hospital of AthensAthens, GreeceTaking people
  • Nosokomeio Paidon I Agia SofiaAthens, GreeceTaking people
  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"Chaïdári, GreeceTaking people
  • University General Hospital of IoanninaIoannina, GreeceTaking people
  • General Hospital Of Larissa Koutlibaneio And TriantafylleioLarissa, GreeceTaking people
  • Olympion Therapeftirio General Clinic Of Patras S.A.Patra, GreeceTaking people
  • Geniko Nosokomeio Thessalonikis George PapanikolaouThessaloniki, GreeceTaking people
  • Ippokratio General Hospital of ThessalonikiThessaloniki, GreeceTaking people

About the trial

What the trial wants to find out

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

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

The 6 groups in the trial

  • Cohort 1a-1bTreatment being tested

    SP-420 for 48 weeks

    Treatment: SP-420

  • Cohort 2a-2bTreatment being tested

    SP-420 for 48 weeks

    Treatment: SP-420

  • Cohort 3a-3bTreatment being tested

    SP-420 for 48 weeks

    Treatment: SP-420

  • 1c-1dTreatment being tested

    SP-420 for 48 weeks

    Treatment: SP-420

  • 2c-2dTreatment being tested

    SP-420 for 48 weeks

    Treatment: SP-420

  • 3c-3dTreatment being tested

    SP-420 for 48 weeks

    Treatment: SP-420

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests SP-420 for removing iron from organs in certain blood disordersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT05693909, who can take part
Record updated
24 September 2025