NCT06073860Recruiting
A Post-Marketing Surveillance Study to Assess Safety of Luspatercept in Korean Patients With Myelodysplastic Syndrome or β-thalassemia
Reblozyl® (Luspatercept) Post-Marketing Surveillance in Korean Patients With Myelodysplastic Syndrome or Beta Thalassemia
Source: ClinicalTrials.gov · Last updated 6 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this observational study is to assess the real-world safety of luspatercept in Korean participants with myelodysplastic syndrome (MDS) or beta thalassemia. Investigators will enroll participants who will begin treatment with at least 1 dose of luspatercept.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 104 (estimated)
- First submitted
- 3 Oct 2023
- Start date
- 25 Mar 2024
- Primary completion date
- 21 Dec 2027
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Myelodysplastic syndromes, Thalassaemia
- NCT number
- NCT06073860
What you commit to
- Study type: Observational
- Planned participants: 104
- From 25 Mar 2024 to the primary completion date, 21 Dec 2027
- 2 sites in 1 country
- 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 for whom luspatercept is contraindicated as clarified in the Korean prescribing information approved by the Ministry of Food and Drug Safety
Other
- Participants who are prescribed luspatercept for therapeutic indications not approved in the Republic of Korea
Who the study is looking for
- Adult participants 19 years of age or older
- Participants who will be treated with luspatercept according to the approved label in the Republic of Korea
- Participants who sign the informed consent form
Age in the registry: 19 years to - · Sex: All
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novotech Laboratory Korea Co., Ltd. Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Terminated |
This page is information, not medical advice. Discuss any trial with your doctor.