An observational study in β-thalassemia, sponsored by Bristol-Myers Squibb. Recruiting at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Bristol-Myers Squibb · Observational
The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East
250 studies on the registry are indexed under Thalassemia; 43 are open to participants now.
This study's planned enrollment of 200 is above the median of 106 across 70 observational studies indexed under Thalassemia.
Browse Thalassemia studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will include adult patients with transfusion-dependent β-thalassemia (TDT) in the Middle East region who have initiated luspatercept treatment
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Luspatercept
According to the product label
Change in transfusion burden
Time frame: Baseline and up to week 144
Change in mean pre-transfusion hemoglobin level
Time frame: Baseline and up to week 144
Change in transfusion-related visits
Time frame: Baseline and up to week 144
Proportion of participants achieving ≥33% reduction in red blood cell (RBC) transfusion burden (number of RBC units transfused) plus a reduction of ≥2 units
Time frame: Baseline and up to week 144
Proportion of participants achieving ≥50% reduction in red blood cell transfusion burden plus a reduction of ≥2 units
Time frame: Baseline and up to week 144
Time from first luspatercept dosing date to the first erythroid response
Time frame: Baseline and up to week 144
Time from the date the erythroid response is first observed until the last day of response
Time frame: Baseline and up to week 144
Participant pretransfusion hemoglobin level
Time frame: Baseline and up to week 144
Participant baseline transfusion burden
Time frame: Baseline
Proportion of participants without red blood cell transfusion during any consecutive 12-week or 24-week treatment period
Time frame: Baseline and up to week 144
Time from first luspatercept dosing date to first onset of red blood cell-transfusion independence ≥12 weeks and ≥24 weeks
Time frame: Baseline and up to week 144
Time from the date a 12-week and 24-week red blood cell-transfusion independence is first observed until the date the participant has a subsequently documented red blood cell transfusion
Time frame: Baseline and up to week 144
Change in mean serum ferritin (SF) level
Time frame: Baseline and up to week 144
Change in proportion of participants with mean serum ferritin <1,000, 1000-2500, and >2,500 μg/L
Time frame: Baseline and up to week 144
Types (drug formulation - mono and combination therapy) of iron chelation therapy received
Time frame: Baseline and up to week 144
Change in mean daily dose of iron chelation therapy from baseline
Time frame: Baseline and up to week 144
Number of medical encounters (inpatient hospitalizations, emergency department attendances, hospital outpatient visits, visits at office-based physicians)
Time frame: Baseline and up to week 144
Inpatient length of stay
Time frame: Baseline and up to week 144
Proportion of participants remaining on luspatercept treatment
Time frame: Up to week 144
Length of time from initiation to discontinuation of luspatercept treatment
Time frame: Up to week 144
Frequencies of reasons for discontinuation of luspatercept treatment
Time frame: Up to week 144
Participant sociodemographics
Sociodemographics of participants such as age, sex, ethnicity, country of treatment, height, weight, and body mass index
Time frame: Baseline
Participant disease characteristics
Disease characteristics of participants, describing age of diagnosis of β-thalassemia, genotype (β0/β0, non-β0/β0), splenectomy status (yes/no), pretransfusion hemoglobin level (mean of all documented), transfusion burden (total number of red blood cell units transfused).
Time frame: Baseline
Participant comorbidities
Disease- and non-disease-related comorbid conditions
Time frame: Baseline
Concomitant treatment(s) received
Disease-related best supportive care (BSC) and treatments for other comorbidities.
Time frame: Baseline
Number of luspatercept doses administered
Time frame: Up to week 144
Number of luspatercept dose modifications
Time frame: Up to week 144
Frequencies of reasons for luspatercept dose modifications
Time frame: Up to week 144
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Feb 2030, 44 months after the start.
Of 23 observational studies under Thalassemia, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 74. This study's planned 44 months is below that.
How these figures are worked out, and which studies are left out of them.
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