NCT07215975Recruiting
A Real-World Study to Evaluate Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East
REal-World Application of Luspatercept in Adults With Transfusion-Dependent Beta-Thalassemia in the Middle East (RELATE): A Non-interventional Retrospective and Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate luspatercept treatment in adults with transfusion-dependent beta-Thalassemia in the Middle East
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 9 Oct 2025
- Start date
- 26 Jun 2026
- Primary completion date
- 28 Feb 2030
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Thalassaemia
- NCT number
- NCT07215975
What you commit to
- Study type: Observational
- Planned participants: 200
- From 26 Jun 2026 to the primary completion date, 28 Feb 2030
- 13 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheikh Shakhbout Medical City (SSMC) Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Recruiting |
| Local Institution - 501 Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Not yet recruiting |
| Local Institution - 503 Coordinator of this site? Confirm its status | Al Ain City | United Arab Emirates | Not yet recruiting |
| Local Institution - 202 Coordinator of this site? Confirm its status | Al Jahra | Kuwait | Not yet recruiting |
| Local Institution - 201 Coordinator of this site? Confirm its status | Andalusia | Kuwait | Not yet recruiting |
| Local Institution - 203 Coordinator of this site? Confirm its status | Kuwait City | Kuwait | Not yet recruiting |
| Sultan Qaboos University Hospital Coordinator of this site? Confirm its status | Seeb | Oman | Recruiting |
| Local Institution - 109 Coordinator of this site? Confirm its status | Al Hofuf and Al Mubarraz | Saudi Arabia | Not yet recruiting |
| Prince Mohammed Bin Fahad Hospital Coordinator of this site? Confirm its status | Al Qaţīf | Saudi Arabia | Recruiting |
| Local Institution - 106 Coordinator of this site? Confirm its status | Dammam | Saudi Arabia | Not yet recruiting |
| Local Institution - 102 Coordinator of this site? Confirm its status | Jizan | Saudi Arabia | Not yet recruiting |
| Local Institution - 105 Coordinator of this site? Confirm its status | Mecca | Saudi Arabia | Not yet recruiting |
| King Saud Medical Complex Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.