Evaluating luspatercept for treating β-thalassemia major in Taiwan
Taiwan β-Thalassemia Major Real-World Study for Luspatercept
This study is testing if a new treatment called luspatercept can help adults with severe β-thalassemia major feel better and improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 5 sites (Kaohsiung and 4 other locations) |
| Trial ID | NCT06596642 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of luspatercept in patients with β-thalassemia major in Taiwan. It will also evaluate the impact of this treatment on patients' quality of life. Participants will be adults who are transfusion-dependent and have a significant transfusion burden prior to starting luspatercept. The study will collect real-world data to provide insights into the treatment's effectiveness in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with transfusion-dependent β-thalassemia major who meet specific transfusion burden criteria.
Not a fit: Patients with hypersensitivity to luspatercept or those requiring treatment for extramedullary hematopoiesis masses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and quality of life for patients with β-thalassemia major.
How similar studies have performed: Other studies have shown promising results with luspatercept in treating β-thalassemia, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants ≥18 years of age. * Participants with the diagnosis of transfusion-dependent β-thalassemia major who are eligible to the treatment of luspatercept. * Before luspatercept treatment, participant's transfusion burden ≥ 24 Red Blood Cell units in 24 weeks, without ≥35-day transfusion free. Exclusion Criteria: * Hypersensitivity to the active substance or to any of the excipients. * Pregnancy. * Participants requiring treatment to control the growth of extramedullary hematopoiesis (EMH) masses.
Where this trial is running
Kaohsiung and 4 other locations
- Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung, Taiwan (Recruiting)
- National Cheng Kung University Hospital — Tainan, Taiwan (Recruiting)
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
- MacKay Memorial Hospital — Taipei, Taiwan (Recruiting)
- Chang Gung Memorial Hospital, Linkou — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.