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Improvement of MRI assessed cerebral Perfusion and oxygenation by luspatercept-induced Anemia Correction in non-transfusion dependent Thalassemia
EU CTIS ID: 2023-504908-28-01
What this study is testing
To assess whether luspatercept can improve the cerebral oxygen metabolism (CMRO2) in patients with non-transfusion-dependent thalassemia (NTDT) with Hb increase of ≥ 1 g/dL
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- NTDT beta-thalassemia
- Baseline Hb level of ≤ 10.0 based on the mean Hb level 24 weeks before initiation of luspatercept g/dL
- ≥ 18 years of age
- ≤ 5 RBC units transfused in the 24 weeks prior to inclusion in the study
- Participants, who if female and of childbearing potential, are using highly effective methods of contraception from study start to 30 days after the last dose of study drug, and who if male are willing to use barrier methods of contraception, from study start to 30 days after the last dose of study drug.
- Participant has provided documented informed consent or assent (the informed consent form [ICF] must be reviewed and signed by each participant; the participant’s legal representative or legal guardian, and the participant’s assent must be obtained).
You likely can't join if
- No informed consent has been given.
- Contra-indication for MRI or acetazolamide
- Female who is breast feeding or pregnant.
- Hepatic dysfunction characterized by alanine aminotransferase (ALT) > 4 × ULN.
- Severe renal dysfunction (estimated glomerular filtration rate <30mL/min).
- History of malignancy within the past 2 years prior to participation requiring chemotherapy and/or radiation (with the exception of local therapy for non-melanoma skin malignancy).
See the full eligibility criteria
- NTDT beta-thalassemia
- Baseline Hb level of ≤ 10.0 based on the mean Hb level 24 weeks before initiation of luspatercept g/dL
- ≥ 18 years of age
- ≤ 5 RBC units transfused in the 24 weeks prior to inclusion in the study
- Participants, who if female and of childbearing potential, are using highly effective methods of contraception from study start to 30 days after the last dose of study drug, and who if male are willing to use barrier methods of contraception, from study start to 30 days after the last dose of study drug.
- Participant has provided documented informed consent or assent (the informed consent form [ICF] must be reviewed and signed by each participant; the participant’s legal representative or legal guardian, and the participant’s assent must be obtained).
- No informed consent has been given.
- Contra-indication for MRI or acetazolamide
- Female who is breast feeding or pregnant.
- Hepatic dysfunction characterized by alanine aminotransferase (ALT) > 4 × ULN.
- Severe renal dysfunction (estimated glomerular filtration rate <30mL/min).
- History of malignancy within the past 2 years prior to participation requiring chemotherapy and/or radiation (with the exception of local therapy for non-melanoma skin malignancy).
- History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to consent, including but not limited to the following: 1. Unstable angina pectoris or myocardial infarction or elective coronary intervention. 2. Congestive heart failure requiring hospitalization. 3. Uncontrolled clinically significant arrhythmias.
- Participated in another clinical trial of an investigational agent (or medical device) within 30 days or 5 half-lives of date of informed consent, whichever is longer, or is currently participating in another trial of an investigational agent (or medical device).
- Medical, psychological, or behavioral conditions, which, in the opinion of the Investigator, may preclude safe participation, confound study interpretation, interfere with compliance, or preclude informed consent.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.