A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia… (NCT07215975) | Clinical Trial Compass
RecruitingNot Applicable
A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East
Oman, Saudi Arabia200 participantsStarted 2026-02-26
Plain-language summary
The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female participants of any race aged at least 18 years at time of initiation of luspatercept treatment
* Participants with documented diagnosis of transfusion-dependent β-thalassemia (TDT).
* Participants who have been initiated on treatment with luspatercept as per the product's Summary of Product Characteristics (SmPC) no longer than 12 months prior to informed consent signature, and for whom therapy is ongoing.
* Participants for whom the decision to prescribe luspatercept treatment is clearly separated from the physician's decision to include the participant in the current study.
* Participants who have provided signed informed consent for participating in the study and for collecting and analyzing medical data pertinent to the objectives of this study
Exclusion Criteria:
* Participants that meet any of the contraindications to the administration of luspatercept as outlined in the latest version of the locally approved SmPC.
* Participants who are currently receiving or are planned to receive treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to luspatercept therapy initiation.
* Participants who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.
* Participants who have not provided signed informed consent for participating in the study and for col…
What they're measuring
1
Change in transfusion burden
Timeframe: Baseline and up to week 144
2
Change in mean pre-transfusion hemoglobin level
Timeframe: Baseline and up to week 144
Trial details
NCT IDNCT07215975
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2030-02-28
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com