NCT07215975 A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East
| NCT ID | NCT07215975 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bristol-Myers Squibb |
| Condition | β-thalassemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-06-25 |
| Primary Completion | 2030-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2026-06-25 with a primary completion date of 2030-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East
Eligibility Criteria
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 collecting and analysing medical data pertinent to the objectives of this study.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07215975 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying β-thalassemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07215975 currently recruiting?
Yes, NCT07215975 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07215975 trial being conducted?
This trial is being conducted at Seeb, Oman, Jizan, Saudi Arabia.
Who is sponsoring the NCT07215975 clinical trial?
NCT07215975 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 200 participants.