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New treatment option for Beta Thalassemia Major Anemia
Official title A Trial Testing SP-420 in Subjects With Transfusion-dependent β-thalassemia or Low-risk Myelodysplastic Syndromes
ClinicalTrials.gov ID: NCT05693909
What this study is testing
What is SP-420?
SP-420 is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for beta thalassemia major anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Thalassemia cohorts:
- 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...
- On a stable dose of iron chelation for at least 4 weeks prior to screening
- Weight ≥ 35kg at screening
You likely can't join if
- β-thalassemia with the structural Hb variants HbS and HbC
- Current MDS
- Current biliary disorder
- Historic or ongoing clinically significant kidney disease
- Unable to undergo trial assessments including MRI e.g. due to claustrophobia in MRI scanner
- Pregnant or nursing women
See the full eligibility criteria
- Thalassemia cohorts:
- 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
- β-thalassemia with the structural Hb variants HbS and HbC
- Current MDS
- Current biliary disorder
- Historic or ongoing clinically significant kidney disease
- Unable to undergo trial assessments including MRI e.g. due to claustrophobia in MRI scanner
- Pregnant or nursing women
- Men who do not agree to practice effective barrier contraception during the entire period Myelodysplastic Syndromes Cohorts: Inclusion criteria:
- 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 criteria:
- Therapy-related MDS or MDS with a known bone marrow fibrosis
- Diagnosis of decompensated liver cirrhosis
- Clinically significant kidney disease, either historic or ongoing
- Uncontrolled ischemic heart disease or uncontrolled arrythmia
- Uncontrolled hypertension
- Uncontrolled dyslipidaemia
- Uncontrolled Diabetes
- Major surgery within 8 weeks prior to screening
- Pregnant or nursing women
- Men who do not agree to practice effective barrier contraception during the entire period
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.