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The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving luspatercept treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Luspatercept | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in transfusion burden | Baseline and up to week 144 | |
| Change in mean pre-transfusion hemoglobin level | Baseline and up to week 144 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in transfusion-related visits | 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 | Baseline and up to week 144 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include adult patients with transfusion-dependent β-thalassemia (TDT) in the Middle East region who have initiated luspatercept treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sultan Qaboos University Hospital | Recruiting | Seeb | Muḩāfaz̧at Masqaţ | 123 | Oman |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| C000621232 | luspatercept |
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| Proportion of participants achieving ≥50% reduction in red blood cell transfusion burden plus a reduction of ≥2 units | Baseline and up to week 144 |
| Time from first luspatercept dosing date to the first erythroid response | Baseline and up to week 144 |
| Time from the date the erythroid response is first observed until the last day of response | Baseline and up to week 144 |
| Participant pretransfusion hemoglobin level | Baseline and up to week 144 |
| Participant baseline transfusion burden | Baseline |
| Proportion of participants without red blood cell transfusion during any consecutive 12-week or 24-week treatment period | 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 | 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 | Baseline and up to week 144 |
| Change in mean serum ferritin (SF) level | Baseline and up to week 144 |
| Change in proportion of participants with mean serum ferritin <1,000, 1000-2500, and >2,500 μg/L | Baseline and up to week 144 |
| Types (drug formulation - mono and combination therapy) of iron chelation therapy received | Baseline and up to week 144 |
| Change in mean daily dose of iron chelation therapy from baseline | Baseline and up to week 144 |
| Number of medical encounters (inpatient hospitalizations, emergency department attendances, hospital outpatient visits, visits at office-based physicians) | Baseline and up to week 144 |
| Inpatient length of stay | Baseline and up to week 144 |
| Proportion of participants remaining on luspatercept treatment | Up to week 144 |
| Length of time from initiation to discontinuation of luspatercept treatment | Up to week 144 |
| Frequencies of reasons for discontinuation of luspatercept treatment | Up to week 144 |
| Participant sociodemographics | Sociodemographics of participants such as age, sex, ethnicity, country of treatment, height, weight, and body mass index | 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). | Baseline |
| Participant comorbidities | Disease- and non-disease-related comorbid conditions | Baseline |
| Concomitant treatment(s) received | Disease-related best supportive care (BSC) and treatments for other comorbidities. | Baseline |
| Number of luspatercept doses administered | Up to week 144 |
| Number of luspatercept dose modifications | Up to week 144 |
| Frequencies of reasons for luspatercept dose modifications | Up to week 144 |
| Prince Muhammad bin Nasser Hospital | Not yet recruiting | Jizan | Saudi Arabia |