Luspatercept for adults with transfusion-dependent beta-thalassemia in the Middle East

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a real-world, observational study collecting medical data from adults treated with luspatercept at participating hospitals in the Middle East. Eligible participants are adults (≥18 years) with documented transfusion-dependent beta-thalassemia who started luspatercept no more than 12 months before giving consent and continue on therapy. Treatment decisions were made independently of study enrollment and luspatercept is given per the product's local Summary of Product Characteristics. The study will analyze clinical outcomes and transfusion burden using routinely collected medical records from the participating sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sultan Qaboos University Hospital
  Seeb, Muḩāfaz̧at Masqaţ, Oman Recruiting
• Prince Mohammed Bin Fahad Hospital
  Al Qaţīf, Saudi Arabia Recruiting
• King Saud Medical Complex
  Riyadh, Saudi Arabia Recruiting
• Sheikh Shakhbout Medical City (SSMC)
  Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates Recruiting
• Local Institution - 202
  Al Jahra, Kuwait Not yet recruiting
• Local Institution - 201
  Andalusia, Kuwait Not yet recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Safety and Effect of HbF Inducers in Beta Thalassemia

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• Gene therapy for patients with β-thalassemia using modified stem cells

  This study is testing a new gene therapy using modified stem cells to see if it can help young people with β-thalassemia reduce their need for blood transfusions.

  Recruiting at 3 sites Phase 1 Shenzhen Hemogen · Guangxi and 2 other locations · NCT06655662

• Long-term treatment with Etavopivat for sickle cell disease and thalassemia

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  Recruiting at 45 sites Phase 3 Novo Nordisk A/S · Birmingham, Alabama and 106 other locations · NCT06609226

• Gene therapy for treating β-thalassemia Major

  This study is testing a new gene therapy to see if it can safely help young people with severe β-thalassemia reduce their need for blood transfusions.

  Recruiting at 3 sites Phase 1 Shanghai BDgene Co., Ltd. · Guangzhou, Guandong and 2 other locations · NCT06465550

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.